Devices, systems and methods for tissue repair

ABSTRACT

Devices, systems and methods are disclosed for repairing soft tissue. The surgical system allows for the creation of tissue repair by grasping, aligning and sewing or fixing tissue. For example, this system may be used for clipping together excessive capsular tissue and reducing the overall capsular volume. The deployment device includes a central grasping mechanism and an outer clip delivery system. The clip embodiments may be single or multi-component (penetration and locking base components) that penetrate tissue layers and deploy or lock to clip the tissue together. An example of the system is used to reduce the joint capsule tissue laxity and reduces the potential for subluxation or dislocation of the joint by either restricting inferior laxity (anterior or posterior) and resolving or eliminating pathologic anterior or posterior translation.

This U.S. Utility patent application claims priority to U.S. ProvisionalPatent Application Ser. No. 60/570,627, filed May 13, 2004, and to U.S.Provisional Patent Application Ser. No. 60/584,585, filed Jul. 1, 2004,the contents of each of which are hereby incorporated by reference intheir entirety into this disclosure.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to devices, systems and methodsfor tissue repair. More particularly, the present invention relates todevices, systems and methods for treating unidirectional andmultidirectional instability of tissue structures.

2. Background of the Invention

Tissue instability or compromise is a common occurrence in all persons,whether induced by age, repeated use, disease, accident or natural andabnormal formation. Such instability may include, for example,intentional or accidental tears, cuts, stretching, loosening,deterioration of structure, loss of firmness, and the like. Furthermore,such tissue may relate to orthopedics, as in the skeletal system and itsassociated muscles, joints and ligaments and the like, or non-orthopedicsystems, such as smooth muscles, gastrointestinal, cardiac, pulmonary,neural, dermal, ocular and the like.

No matter what type of instability is present or whether the tissue tobe repaired is classified as orthopedic or non-orthopedic, similarissues and objectives are encountered by the surgeon, namely, creating astable and reliable structure and doing so in as easy and reliablemanner as possible. For example, a neurosurgeon aims to create a stableand reliable adhesion of two neural tissue structures, while at the sametime creating minimal damage. The neurosurgeon desires a technique thatis minimally invasive, highly reproducible and reliable, and highlyeffective in connecting the tissue to itself or other similar ordissimilar tissue. It would be even more beneficial to somehow have thetissue become induced to adhere to itself or the other tissue.

In another similar example, in orthopedics soft tissue surgery, thesurgeon desires to repair the damaged or diseased tissue in such amanner such that the tissue binds with itself or other tissue in a firmbut minimally damaging manner. In muscle or ligament repair, forexample, it is necessary to suture the tissue together to promotestrength and unity in the structure while at the same time, allow fornatural movement to occur.

More broadly, traditional soft tissue repair is a common procedure thattypically involves some form of conventional suturing or stapling. Forexample, certain joints, such as hips, knees, shoulders and elbowscontain tissues that are common sources of problems, whether natural orinduced, that require extensive physical therapy or surgery to correct.There are similarities between such examples of tissues that present auniform set of issues for the health care worker such that a treatmentof one type of tissue will be in many ways similar to the treatment ofanother type of tissue, even though the shape, properties andarchitecture of each tissue is uniquely different. Of such tissues ortissue structures, a common source of medical problems occurs in thejoints. Although the below example will be described with respect to theshoulder joint as an example, similar problems are inherent in othersoft tissue areas and one having ordinary skill in the art would becognizant of such problems and how to apply the principles of thepresent invention to address the problems in such other tissues ortissue systems.

Joint instability is a complex clinical problem associated with avariety of treatment options that include the use of arthroscopic andopen surgical methods. For example, for the shoulder joint, opensurgical methods for producing a capsular shift to increase the capsularligament tension and improving the joint stability have beendemonstrated. However, adequate arthroscopic methods that approximatethe clinical outcome achieved by open surgical methods for reducingexcessive joint laxity have been slow to develop or have begun to showless than optimal long term clinical outcomes (e.g., thermal methods).

The shoulder joint, in particular, has inherent instability because ofits large range and motion combined with the relatively shallow jointbony socket (glenoid). Anatomically, the rotator cuff acts as theprimary dynamic joint stabilizer, while the inferior glenohumeralligament acts as the primary static shoulder joint stabilizer. Damage toor laxity of one of these stabilizing structures can result in thepresentation of clinically relevant shoulder instability.

The onset of shoulder instability is generally associated with atraumatic injury, an atraumatic motion injury, or chronic overuse of theshoulder. Most typically, the instability of the shoulder stems fromdisruption and/or looseness (excessive capsule laxity) of the shouldercapsule. The resulting subluxation or dislocation of the joint can bepainful and debilitating for the individual. The overall approach ofshoulder stabilization surgery is to first repair the disrupted/torncapsule and second to tighten the loose capsule ligaments. Of note thereare instances where the capsule is intact (e.g., no tear) and onlytightening of the capsule ligaments is required to restore jointstability. The ultimate goals of shoulder stabilization includerestoring appropriate capsule tension, limiting of humeral headtranslation, and excessively decreasing range of motion.

Up to 98% of all shoulder joint dislocations occur in the anteriordirection, 95% of which are first time dislocations. Over 70% of theseindividuals will have recurrent instability (subluxation or dislocation)within two years after the first event, potentially requiring surgicalintervention.

Certain conventional devices serve to assist with repair of the shouldercapsule when it is disrupted, such as in the case of Bankart Lesions. Itis noted that Bankart Lesions are identified by the characteristicstripping/tearing of the anterior inferior labrum from the glenoid.Treatment of these lesions is typically accomplished through a standardopen incision or with existing arthroscopic technology.

Clinically described excessive joint laxity in the joint capsule canrange from 1.0 to more than 20.0 mm in ligament elongation, resulting inrecurrent glenohumeral subluxation or dislocation. A loose shouldercapsule may be tightened readily when a standard open incision is used,but tightening the shoulder capsule arthroscopically poses significantchallenges with existing instruments. For example, the acute angles atwhich the surgical devices are able to approximate the soft tissue andidentify regions where suturing would be desirable are limiting.Furthermore, the ability to pass a suture and tie snug surgical knotsthat compress the tissue in the desired plane with a reasonable suturetime is difficult if not cumbersome. Finally, the ability to dictate thelevel of tissue tied is limited to the tissue needle bite size andremains difficult for the surgeon to reproducibly specify the level oftissue compression desired.

A recently introduced technology, thermal capsulorrhaphy, initially heldsignificant promise as a means of facilitating and expeditingarthroscopic shoulder capsule tightening. The premise of this techniqueis to manipulate the characteristics of the approximately 90% Type Icollagen structure of ligaments by thermal exposure. It has beendemonstrated that at temperatures above 65 degrees Celsius, collagenbegins to denature (e.g., unwinding of the helical structure), resultingin tissue shrinkage. Collagen shrinkage of up to 50% has beendemonstrated using thermal energy. However, this technology has yieldedequivocal results and progressive skepticism from shoulder surgeons.Specifically, concerns related to long term clinical outcomes forshoulder instability with altered capsular structure have been noted.There is a strong current sentiment among shoulder surgeons thattightening the shoulder capsule by plication with sutures will prove tobe more efficacious and more reproducible than the use of thermalmechanisms to reduce the ligament laxity in the capsule.

Additional concerns of thermal capsulorrhaphy application includepotential injury to the axillary nerve, bleeding, pain, and excessiveswelling of the capsule. More importantly, the technical methods usedduring thermal capsulorrhaphy do not allow the surgeon to control thelevel of plication that is desired or anticipated. Specifically, thermalmethods are technique-specific and have a required learning curveassociated with obtaining specified clinical plication outcomes.Moreover, once treated, the level or resulting tissue alterationachieved is irreversible. The paucity of data demonstrating thelong-term mechanical characteristics and viability of these treatedligaments limits the confident and continued use of this technique.

Conventional methods for arthroscopic plication of the shoulder capsulewith sutures typically involve freehand techniques that are technicallychallenging and often time-consuming. An additional shortcoming commonto both thermal capsular shrinkage and existing suturing techniques isthat neither method can effectively control the amount of capsulartightening in a calibrated fashion. “Over-tightening” of the anteriorcapsule can lead to problems such as excessive loss of externalrotation, limiting shoulder joint function.

Thus, a need exists in the art for an alternative to the conventionalmethods of tissue repair. There is a need in the art for novel systemsand methods for arthroscopic soft tissue repair and/or plication that isadaptable to any soft tissue or soft tissue system and can overcome theshortcomings of conventional methods and improve the clinical outcome aswell as be generally adopted by surgeons.

SUMMARY OF THE INVENTION

The present invention provides an alternative and enhancement toconventional methods of tissue repair. More specifically, the presentinvention presents devices, systems and methods for arthroscopicallytreating unidirectional and multidirectional instability of tissue ingeneral, and through suturing and/or plication by non-limiting example.An essential and powerful aspect of this invention is its wideapplicability to a non-limiting extent of tissues and tissue systems ofany shape or size, such as, for example the plication of loose tissuefrom the interior surface of a spheroidal capsule. One having ordinaryskill in the art is cognizant of the applicability of the presentinvention to as diverse fields as reduction in gastric reflux to lungvolume reduction to atrial valve repair and shoulder joint plication.The present invention is not limited to the examples set forth in thisdisclosure but is extended to all other procedures that would benefitfrom the devices, systems and methods as described herein. Thus, thescope of the present invention extends beyond the non-limiting examplesset forth herein and encompasses that which would be or should be withinthe purview of one having ordinary skill in the art of tissue repair.

In one described embodiment, the invention relates to suture structuresand related deployment devices to repair, plicate and/or reduce thecapsular laxity at the glenohumeral joint, improving joint stability.However, the techniques disclosed in the examples below are adaptableand usable for all tissues and tissue systems where repair is beneficialto improve the health and function of the tissue or tissue system. Suchtechniques and uses, particularly relating to embodiments of the presentinvention, are particularly useful in applications requiring transdermalaccess to a particular internal tissue by penetrating one or more layersof tissue. However, such transdermal access is not limiting and thepresent invention may be applicable in non-transdermal applications aswell, such as in fundoplication. Further, “repair” of such tissue, asdefined herein and throughout this disclosure, is a slowing down orreversal of the instability such that the tissue is somehow manipulatedto deal with or overcome the instability, usually involving some form ofsurgery. Common, but not limiting, examples include suturing, plicating,stapling, restructuring, adhering, tightening, attaching, firming or thelike.

In one exemplary embodiment, the present invention is a system fortransdermal repair of soft tissue. The system comprises a first elementto pinch a portion of soft tissue that is to be repaired; a secondelement to repair the portion of soft tissue that is pinched by thefirst element, such portion of soft tissue being accessed transdermally;and a third element to deploy the first element and the second elementin turn to repair the portion of soft tissue that is being pinched.

In another exemplary embodiment, the present invention is a system forplicating a capsular structure. The system comprises a pinching elementto pinch a portion of an interior surface of a capsular structure to beplicated; a plicating element to plicate the portion of the interiorsurface of the capsular structure that is pinched by the pinchingelement; and a deployment element to deploy the pinching element and theplicating element in turn to plicate the portion of the interior surfaceof the capsular structure that is being pinched.

In yet another exemplary embodiment, the present invention is a methodfor arthroscopic plication of an interior concave surface of a capsularstructure. The method comprises pinching a portion of the interiorconcave surface of the capsular structure; and securing the portion ofthe interior surface that is pinched.

In yet another exemplary embodiment, the present invention is a methodfor arthroscopic repair of soft tissue within a hollow structure. Themethod comprises pinching a portion of soft tissue on the interiorsurface of the hollow organ; and fixing the portion of soft tissue thatis pinched.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a graphical cross-sectional illustration of conventionalarthroscopic instrument position relative to anatomic structures.

FIGS. 2A and 2B show an exemplary arthroscopic plication deploymentdevice according to the present invention in a capsular region withclips positioned in the areas of plication.

FIGS. 3A to 3D show an exemplary grasper mechanism according to thepresent invention during advancement and grasping of a tissue pleat.

FIGS. 4A and 4F show an exemplary embodiment of the deployment deviceaccording to the present invention.

FIGS. 5A to 5E show a distal end of an exemplary deployment deviceaccording to the present invention demonstrating a method of tissueplication.

FIGS. 6A to 6L show a distal end of an exemplary deployment deviceaccording to the present invention demonstrating a method of tissueplication.

FIGS. 7A to 7J show a distal end of an exemplary deployment deviceaccording to the present invention demonstrating a method of tissueplication.

FIG. 8A to 8I show a distal end of an exemplary deployment deviceaccording to the present invention demonstrating a method of tissueplication.

FIGS. 9A to 9G show a distal end of an exemplary deployment deviceaccording to the present invention demonstrating a method of tissueplication.

FIGS. 10A to 10D show an embodiment of the distal tip and shaft of theplication deployment device according to the present invention.

FIGS. 11A to 11H show an exemplary embodiment of the distal tip andshaft of the plication deployment device according to the presentinvention with an exemplary embodiment of a clip device at a distal tipof the jaws.

FIG. 12A to 12E show exemplary deployment device jaws with needleretrieval elements according to the present invention.

FIGS. 13A to 13D show a procedural deployment of a hinge lock plicationclip using a grasping mechanism according to an exemplary embodiment ofthe present invention.

FIGS. 14A to 14D show a procedural deployment of a hinge lock plicationclip without a grasping mechanism according to an exemplary embodimentof the present invention.

FIGS. 15A to 15C show a procedural use of a neurostimulator to verifythe position of the axillary nerve relative to the area of plicationaccording to an exemplary embodiment of the present invention.

FIGS. 16A to 16C show a top, side and prospective views of a deploymentdevice containing a single armed anchoring device and a suture retrievalmechanism according to an exemplary embodiment of the present invention.

FIGS. 17A to 17D show an exemplary procedural use of an exemplary deviceaccording to the device shown in FIG. 16.

FIGS. 18A to 18D show a three-pronged grasper device mechanism accordingto an exemplary embodiment of the present invention.

FIGS. 19A and 19B show a two pronged grasper device mechanism accordingto an exemplary embodiment of the present invention.

FIGS. 20A and 20B show an undeployed single armed grasper anchormechanism according to an exemplary embodiment of the present invention.

FIGS. 21A and 21B show a deployed single armed grasper anchor mechanismaccording to an exemplary embodiment of the present invention.

FIGS. 22A and 22B show a deployed single armed grasper anchor mechanismaccording to an exemplary embodiment of the present invention.

FIG. 23 shows a distal tip and shaft of a plication deployment deviceaccording to an exemplary embodiment of the present invention.

FIGS. 24A to 24B show an embodiment of a distal tip and shaft of aplication deployment device according to an exemplary embodiment of thepresent invention.

FIGS. 25A to 25C show an embodiment of a distal tip and shaft of aplication deployment device according to an exemplary embodiment of thepresent invention: (a) from the side; (b) view from bottom jaw lookingtoward top jaw; and (c) a perspective view.

FIG. 26 shows a distal tip and shaft of a plication deployment deviceaccording to an exemplary embodiment of the present invention.

FIGS. 27A to 27F show an embodiment of the plication delivery deviceaccording to an exemplary embodiment of the present invention with adistal tip in the closed and open positions and a bottom flange having aflexible member that may be displaced to expose a penetrating element.

FIGS. 28A to 28D show a plication delivery device according to anexemplary embodiment of the present invention with a distal tip in theclosed and open positions and a bottom flange having a flexible memberthat may be displaced to expose a penetrating element.

FIGS. 29A to 29F show a plication delivery device according to anexemplary embodiment of the present invention with a distal tip in theclosed and open positions and a bottom flange having a flexible memberthat may be displaced to expose a penetrating element.

FIGS. 30A to 30F show a plication delivery device according to anexemplary embodiment of the present invention with a distal tip in theclosed and open positions and a bottom flange having a flexible memberthat may be displaced to expose a penetrating element.

FIGS. 31A to 31D show a plication delivery device according to anexemplary embodiment of the present invention with a distal tip in theclosed and open positions and a bottom flange having a flexible memberthat may be displaced to expose a penetrating element.

FIG. 32 shows a flexible delivery device shaft according to an exemplaryembodiment of the present invention to allow for approaching plicationsurface at various angles.

FIGS. 33A and 33B show an internal capsular plication according to anexemplary embodiment of the present invention by grasping the tissue andsliding a plicating clip over the tissue fold and the final plicationwith clip in position.

FIGS. 34A to 34D show perspective, top, and side views of a twocomponent plication device according to an exemplary embodiment of thepresent invention that contains a single point of penetration.

FIGS. 35A to 35C show perspective, top, and side views of a twocomponent plication device according to an exemplary embodiment of thepresent invention that has two points of penetration, extending theregion of attachment and distributing the stresses on the device.

FIGS. 36A to 36F show perspective, top, and side views of a twocomponent plication device according to an exemplary embodiment of thepresent invention that has two points of penetration, extending theregion of attachment and distributing the stresses on the device.

FIGS. 37A to 37C show perspective, top, and side views of a twocomponent plication device according to an exemplary embodiment of thepresent invention that has two points of penetration, extending theregion of attachment and distributing the stresses on the device.

FIGS. 38A to 38E show perspective, top, and side views of a twocomponent plication device according to an exemplary embodiment of thepresent invention that has two points of penetration, extending theregion of attachment and distributing the stresses on the device.

FIGS. 39A to 39C show perspective views of a two component plicationdevice according to an exemplary embodiment of the present inventionthat includes two locking positions.

FIG. 40A to 40D show perspective and side views of a two componenthinged plication device according to an exemplary embodiment of thepresent invention.

FIGS. 41A to 41F show a two component sleeve-lock device with multiplestages according to an exemplary embodiment of the present invention.

FIGS. 42A to 42F show a perspective, top, and side views of a singlecomponent plication device according to an exemplary embodiment of thepresent invention in the undeployed and deployed configuration. Thisembodiment can also include use with a pledget backing making it a twocomponent plication device.

FIGS. 43A to 43C show perspective and side views of a single componentspring plication device according to an exemplary embodiment of thepresent invention along with illustrations of device implementation.

FIG. 44A to 44C show a perspective view of a single component plicationdevice according to an exemplary embodiment of the present invention.

FIG. 45A to 45C show a perspective and top views of a single componentplication device according to an exemplary embodiment of the presentinvention.

FIG. 46A to 46D show a perspective and side views of a single componentplication device according to an exemplary embodiment of the presentinvention.

FIG. 47A to 47C show a perspective and top views of a single componentplication device according to an exemplary embodiment of the presentinvention.

FIG. 48A to 48C show perspective, top, and side views of a singlecomponent plication device according to an exemplary embodiment of thepresent invention.

FIG. 49A to 49E show perspective, top, and side views of a singlecomponent plication device according to an exemplary embodiment of thepresent invention.

FIG. 50A to 50F show perspective, top, and side views of a singlecomponent plication device according to an exemplary embodiment of thepresent invention.

FIG. 51A to 51C show a perspective and top views of a single componentplication device according to an exemplary embodiment of the presentinvention.

FIGS. 52A to 52C show a plication of the capsule to the labrum usingdevice clip devices according to an exemplary embodiment of the presentinvention.

FIG. 53 shows lung volume reduction application with suture or cliptissue fixation according to an exemplary embodiment of the presentinvention.

FIG. 54 shows a laparoscopic gastric fundoplication with laparoscopicsuture or clip tissue fixation according to an exemplary embodiment ofthe present invention.

FIG. 55 shows a thorascopic lung reduction procedure with thorascopicsuture or clip tissue fixation according to an exemplary embodiment ofthe present invention.

FIG. 56 shows a thorascopic mitral valve repair with thorascopic sutureor clip tissue fixation according to an exemplary embodiment of thepresent invention.

FIGS. 57A and 57B show an exemplary atrial appendage isolation (orremoval) procedure on the heart according to an embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to devices, systems, and methods thataddress deficiencies in conventional methods of tissue repair. Thepresent invention may be applied to a number of different medicalapplications, including but not limited to repair and/or plication orattachment of soft tissue, such as lung reduction or resection, gastricreduction, intestinal, liver reduction or resection, kidney reduction orresection, esophageal modification, atrial appendage isolation orremoval, and anatomic structures. These are mere examples of locationswhere such devices, systems and methods may be used and in no way arelimiting of the broader scope of the present invention.

The devices, systems and methods according to the present invention maybe applied to any tissue or tissue structure in any geometry. Forexample, exemplary embodiments of the present invention may be used toplicate a capsular joint from the interior concave surface of thecapsular joint by connection to and mending or suturing of the interiorcapsular tissue. This ability is one of the advantages of the presentinvention and is characteristic of its diverse range of application interms of tissue targets as well as target shape and/or geometry.Conventional methods of plication are either limited to repair from anexterior convex surface of a capsular joint or by traditional handsuturing.

For sake of demonstration, exemplary embodiments of the presentinvention are shown by providing a technically facile means ofarthroscopic plication of the shoulder capsule using a tissue clip orsuturing device deployed with a single calibrated hand-held device forthe treatment of unidirectional and multidirectional instability of theshoulder joint. The exemplary embodiments of the invention addressdeficiencies in shoulder capsule ligament plication for shoulder jointstabilization. The same or similar techniques as shown with respect tothe shoulder capsule may also be used in virtually any other tissue ortissue structure that could benefit from the embodiments of the presentinvention. In addition, the exemplary embodiments address similardeficiencies that are apparent in other applications involving plicationof tissues such as lung reduction or resection, gastric reduction orbypass, intestinal modifications, liver reduction or resection, kidney,esophageal, atrial appendage isolation or removal, cardiac tissueplication or attachment, and other soft tissue attachment or plicationreductions.

A primary purpose of the present invention as shown in some of theexemplary embodiments is to better enable the tightening of the shouldercapsule ligaments either concomitantly or as a primarily course oftreatment rather than to specifically repair a disrupted capsule. Theexpected clinical outcome includes reducing or eliminating any excessanterior inferior translation of the joint as well as resolving anypathologic anterior or posterior translation of the joint, therebystabilizing the shoulder.

The exemplary plication systems according to the present invention mayalso be used to reduce or plicate, or attach soft tissue structures forother applications including, but not limited to, applying tension toremove slack in other joint ligaments (e.g., anterior cruciate ligament,medial collateral ligament), re-attaching partially or completely tornsoft tissue structures during applications such as meniscus repair,re-attaching partially or completely detached soft tissue structures tobones via bone anchors during rotator cuff repair, Bankart Lesionrepair, or other soft tissue to bone attachment procedure, plicatinghernias, clipping lung tissue during lung reduction or resectionprocedures that result in reduced lung volume, gastric reduction orbypass procedures involving plication of the stomach or intestines toreduce the volume of the anatomy, atrial appendage isolation or removalinvolving clipping the atrial appendage at the orifice to reduce theatrial volume and isolate the interior of the atrial appendage from thecirculating blood pool, vessel ligation procedures, tubal ligationprocedures, resection of cancer tissue (e.g., liver, breast, lung,colon, etc.), mitral valve repair (leaflet and annular ring) and otherprocedures which may require soft tissue plication or attachment.

Additionally, various exemplary embodiments of the present invention aredescribed that may be used to repair, plicate and reduce capsular laxityby attaching the capsule to the glenoid labrum or surrounding bonystructures in the glenohumeral joint. The deployment devices are capableof grasping the capsular tissues, aligning capsular tissues into theplication region of the device, and deploying a plication clip into thetissue to securely attach the folded tissues. The exemplary deploymentdevices have the ability to adjust the level of plication by variablepull back of the grasping element or by variable adjustment of the clipdevice. Furthermore, the exemplary deployment devices may be used toabrade the plicated tissue section to irritate the synovium, elicitingthe biological healing and remodeling response of the soft tissue. Thedimensions of the exemplary devices may be tailored for orthopedicaccess with standard arthroscopic equipment. Additionally, the exemplarydeployment devices may reposition capsular tissue, or other tissue, andsecure tensioned capsular tissue, or other soft tissue, to the labrum,bone, or other anatomy.

By example, the present invention relates to devices, systems andmethods that enable plication of ligaments, tendons, and/or other softtissue structures to reduce unidirectional and multidirectionalinstability of the shoulder, or other anatomic structure. The region ofinterest includes the entire 360 degrees of the joint capsule. However,more typically the repair covers approximately 180 degrees (from the 8o'clock to 2 o'clock anterior position of the capsule). In the instanceof multidirectional instability it is common for a surgeon to close therotator interval that will restrict the anterior and posterior inferiorjoint laxity and thereby restricting or limiting translation.

In exemplary embodiments of the present invention relating to theshoulder joint, capsular tensioning regions of interest include, but arenot limited to, the posterior—inferior and anterior—inferior quadrantsof the glenohumeral joint capsule as well as the rotator cuff interval.Capsular plication with device clip embodiments or suture embodimentsincludes, but is not limited to, capsule-to-labrum plication andcapsule-to-capsule interval closure/reduction. An advantage of thecapsule-to-labrum plication includes augmentation of the labral shelf byincreasing the size of the labral “bumper,” reducing the potential forjoint subluxation or dislocation.

To accomplish joint stability using the exemplary devices, systems andmethods described herein, standard surgical preparation of the site andarthroscopic portals for access of the shoulder joint are performed. Thejoint may be dilated with an arthroscopic pump. The deployment device isintroduced through a standard 5, 6 or 8 mm cannula placed in theanterosuperior arthroscopy portal. The anterior and posterior sectionsof the capsule may be visualized via placement of the arthroscopethrough the accessory anterior inferior portal or the posterior portal.Regions of the anterior and posterior inferior glenohumeral ligament areassessed and identified for removal of excess capsule laxity byplication with the primary goal of reducing the overall capsular volume.The deployment device is moved into position over the ligament region tobe reduced/plicated. The tissue grasping mechanism is deployed throughthe centerline of the deployment device jaws, creating a tissue foldthat is drawn up to and into the jaws of the deployment device. Toimprove the angle of approach of the deployment device in relation tothe capsular plication region, the shaft of the device can be designedto have different configurations, including but not limited to straight,angled, or curved (S or C-shaped) shaft or angled distal jaw region.

Various embodiments can be utilized for the tissue grasping mechanismand include, but are not limited to, jaw clamp with or without an activehinge, J-hook (made of deformable metal, superelastic material, orplastic), penetrating tip element with a deploying end (e.g., umbrella,balloon, or T-shaped) that resists pullout of the device, or a corkscrewdesign (made of deformable metal, superelastic material, or plastic). Acommon ability with tissue grasping mechanisms is the ability to grab,hold, and move tissue into the jaws of the deployment device. Theadvantage of using a grasping mechanism to align the tissue and bringthe tissue into the deployment device jaws is the ability to adjust thelevel of plication that will be employed. The force required to pullback the tissue into the deployment device jaws is maintained by thegrasping mechanism through a spring or elastic joint/hinge. The jaw ofthe deployment device may have a center channel which enables closing ofthe jaw without being impeded by the grasper.

An exemplary embodiment of the deployment device includes an electrodestimulator that can be engaged along with the grasping mechanism or theclamping mechanism. (See, for example, FIG. 15.) The purpose of thestimulator is to identify the potential proximity of the axillary nerve(other nerve or muscle tissue) to the plication region prior todeploying the tissue plication clip. The axillary nerve is typicallylocated within 1-2 cm of the inferior capsule. In short, the graspingmechanism can include coupling of a stimulator element that can beexcited to a level that would invoke activation of the axillary nerveand corresponding muscular response (e.g., deltoid muscle contraction)if the area of plication is located at or near the position of theaxillary nerve. Any indication of muscle stimulation will provide awarning mechanism to the surgeon of the close proximity of the axillarynerve structure and potentially prevent unintended damage to the nerve.

Several strategic locations along the deployment device jaw will haveembodiments that allow for tissue penetration (e.g., needles, barb)and/or abrasion (e.g., rasp or roughened) of select regions of theligament tissue. This stimulation/abrasion of the ligament is intendedto occur simultaneous with engagement of the deployment device jaw. Thepurpose of this penetration and/or abrasion is to elicit a biologicalresponse that promotes more rapid healing and remodeling/scarring of theplicated ligament tissue by irritating the synovium.

Some exemplary embodiments of the suture device may include the use offlexible and rigid elements, suture or suture materials, and pledgetbackings that may allow for proper securing of the plicated or attachedsoft tissue. The embodiments of the deployment device jaw may includemechanisms to engage the suture to the jaws (e.g., at the distal tip,along the jaw flange). One flange of the jaws holds the penetratingelement of the suture device, while the opposite side has locking portsto grab the suture tips. Engagement of the jaws is performed by useractuation of the proximal handle. Upon engagement of the deploymentdevice jaw, with the plicated tissue grasped and aligned, the suturetips engage the tissue between the jaws, penetrate the tissue, andengages with the opposite locking ports. Once full engagement of thedeployment jaw has been achieved, the suture ends have been fullydeployed through the tissue fold to be plicated, the suture tips will belocked into the jaw flange. The deployment device jaw is then opened,and tissue released. The deployment device is then withdrawn from thesite along with the suture ends. The suture ends are retrieved by thesurgeon and standard sliding knots are tightened and locked by pullingthe free end of the suture and advancing the knot to the plication site.The shoulder is then placed through a trial range of motion while thetension portion of the capsule is visualized with the arthroscope.Adequate fixation of the capsular plications is verified.

Exemplary embodiments of the suturing device mechanism may also includevarious locking port configurations which do not require passing ofrigid suture tips, but rather suture ends. Further embodiments alsoincludes passing of multiple sutures during one deployment that can bedistributed in different configurations along the phalanges of the jaw(e.g., perpendicular, parallel, overlapped, cross-over, etc.). Otherembodiments may also include pre-tied suture devices and/or pledgetbackings.

Surgically, the reduction in ligament laxity is continued and repeatedalong and round the capsule, deploying as many suture devices that maybe required and in any 3-dimensional geometric pattern around thecapsule to reduce capsular volume and stabilize the joint. Deployment ofmultiple devices can be required during the capsular laxity treatmentprocedure. This is particularly true for the treatment ofmultidirectional instability of the shoulder. The number, orientationand position of deployed clip devices will be user defined, nolimitation is specified. Furthermore, the level of capsular plication orreduction in capsular laxity will be user defined, no limitation isspecified. Furthermore, it should be noted that various embodiments ofthe suture device may be deployed in each case, particularly in caseswhere a combination of capsule to capsule and capsule to labrum orcapsule to glenoid plication are indicated.

It should be appreciated that the plication devices described, includingsutures and deployment mechanisms, can be applicable for use in otherindications involving devices that are used for plicating and attachingtissue layers where small arthroscopic access is required. Theembodiments of this invention can be tailored to human anatomy, however,they may also be tailored for use in other species such as horses, dogs,sheep, and pigs as well as invertebrates.

These plication systems can be used to reduce or plicate soft tissuestructures or attach tissue layers for application including, but notlimited to, other joint ligaments (e.g., anterior cruciate ligament,medial collateral ligament), rotator cuff repair, Bankart Lesions,meniscus repair, hernias, lung resection, gastric reduction procedures,cancer tissue removal (e.g., liver, breast, colon, lung, etc.), andother procedures which may require soft tissue plication. One havingordinary skill in the art would be cognizant of the procedure to use inperforming the above operations using the exemplary devices describedherein.

The exemplary embodiments of the present invention provide additionaladvantages that include, but are not limited to: providing anarthroscopic approach for the plication and reduction in ligamentlaxity; reducing the visible scars associated with open surgicalprocedures by small port access required by the deployment device;reducing the complexity associated with arthroscopic knot tying;reducing the incidence of axillary nerve damage by a verification ofdevice positioning; enabling a maneuverable and rapid deployment ofplication sutures, reducing the required surgical time as well as thelevel of complexity associated with the procedure; allowing foradjustable and reproducible levels of tissue plication; adding theoption of releasability and removability of a device from the plicationregion; minimizing potential damage to the articular surface by usingdevices and materials that can be secured to the tissue as well as haveless abrasive properties relative to tissue; and using activeembodiments of the device which may allow for diagnostic measurement ofpositioning relative to neuromuscular tissues and active tensioning ofplication regions.

Although many examples below are provided with respect to the shouldercapsule and using a plication procedure, these are only exemplary andare used for their sake of simplicity. Wherever the term “plication” isused with respect to the examples, the broader term “repair” may besubstituted to refer to surgical procedures that may not necessarily beplication. Similarly, the shoulder capsule, as described in the examplesbelow, may be substituted by any other tissue or tissue structure thatcould also benefit from the procedure as described below.

A conventional arthroscopic approach to the glenohumeral joint with thehumeral head removed for clarity is shown in FIG. 1. A standardposterior portal for diagnostic arthroscopy is shown along with twoanterior portals created using an outside-inside technique, approachingthe joint through the rotator interval area above the subscapularistendon. An additional accessory superior posterior inferior portal canalso be created. From a combination of these portal positions, astandard diagnostic glenohumeral arthroscopic examination can beperformed. This includes examination of glenohumeral ligament laxity ordamage at the glenoid labrum region of the joint. Excessive ligamentlaxity or excessive capsular volume is identified by the ability to movethe arthroscope from the posterior to anterior inferior glenohumeralligament space without much difficulty. Once capsular laxity isidentified, methods for plication or reduction in the excessive tissueare performed in order to improve the joint stability. Clinical resultssuggest that the combination of arthroscopic plication of theglenohumeral ligaments in combination with thermal shrinkage procedurescan provide results similar to those observed with open surgicalprocedures. However, as is typically the case, open surgical techniqueshave an increased risks associated with further tissue damage andinfection than through arthroscopic means.

The present invention may be used arthroscopically, shown in FIGS. 2A to2B as a schematic cross-sectional drawing of an arthroscopic approach ofthe glenohumeral joint with the humeral head removed for clarity. Thesefigures demonstrate the insertion and position of an exemplaryembodiment of an arthroscopic deployment device 232 according to thepresent invention in position (A) during pre-deployment and in position(B) during post-deployment of exemplary clip plication devices accordingto the present invention. The clip plication devices shown in thesefigures are a single example of the many exemplary embodiments that maybe used herein and are described in this disclosure. Additionally, theposition, orientation, and location of the clip devices are intendedonly for representation, and do not limit or dictate the positions,orientations, location, and number of devices that should be used. Onehaving ordinary skill in the art would be cognizant of the position,orientation, location and number to use for a specific purpose withoutundue experimentation. Furthermore, the figures shown here andthroughout this disclosure are not intended to be drawn to scale, butrather are for illustrative purposes.

An exemplary embodiment of the capsular grasper is shown in FIG. 3. Thisembodiment is comprised of a distal tip 302 that has articulatingcantilevered arms 303 with teeth that can perforate the shoulder capsuletissue 301 when deployed using a handle 310 (shown partially). Thegrasper is advanced forward to position it in contact with the capsuletissue 301. The cantilevered arms 303 with teeth engage the capsuletissue 301 and clasp the tissue as the articulation is closed forming atissue pleat, such as shown in FIG. 3D. Articulation of the graspermechanism is controlled at the proximal handle 310. The grasping of thetissue pleat permits the ability to provide traction on the shouldercapsule and mobilize the pleat into the jaws of the plication deploymentdevice embodiment.

In another exemplary embodiment of the invention shown in FIG. 4, adistal tip of a plication deployment device 304 is shown in more detail.The device is composed of a grasping embodiment positioned at thecenterline of the jaws and two articulating phalanges 305 and 306(forming the device jaw). The grasping embodiment as shown, can beextended beyond the mouth of the device jaw, grasp tissue, and bring thetissue back into the jaws. The upper and lower phalanges 305 and 306 ofthe device are articulating elements that are controlled at the devicehandle 310 by the user. In an exemplary embodiment, one phalange 308embodies two hollow spikes 308 that upon closure of the jaw willperforate a retracted capsular pleat 331. The phalange on the oppositeside 306 embodies two circular orifices 309 that are in-line with thespikes 308 and act to capture the spikes of the other phalange when thejaw is closed, as shown in FIG. 4B. To facilitate the jaws ability tocompletely close, the phalanges 305 and 306 have channels that can bethrough thickness, allowing the grasper to sit within the jaws, but notimpede actuation or closure of the jaws. In other embodiments, one ofthe phalanges may be fixed, thereby having only one articulatingphalange of the jaw. In other embodiments, the spiked phalange can haveonly one hollow spike or more, for example, up to 6 hollow spikes.

It should be appreciated that in the embodiment shown in FIG. 4, theshaft of the capsular grasper 302 is contained in the shaft of theplication deployment device 304. In other embodiments, the shaft of thecapsular grasper 302 may also be contained adjacent or off center to thejaws of the plication deployment device. In the embodiment where thecapsular grasper is at the centerline of the device, this relationshippermits the grasper to piston axially within the passer so thatretraction of the deployed grasper delivers the capsular pleat into thejaws of the deployment device. Furthermore, in another embodiment, theextent of pistoning or displacement of the capsular grasper within theshaft of the deployment device can be calibrated. This calibrationpermits quantification of the length (size) of the capsular pleat and,hence, the amount of tightening of the shoulder capsule (e.g., moreretraction of the grasper creates a larger pleat which, in turn affectsthe tightness of the capsule). The handle 310 may have various triggers311 and 312 to allow the movement of the shafts of the grasper 302, thesuture passer 304 and the suture retriever 313 relative to one another.

Another exemplary embodiment for passing suture to secure the pleat ofthe capsule is shown in FIG. 5. In this figure, a suture retrieval arm313 is contained within one of the phalanges 306 in the plicationdeployment device. An embodiment of the suture retrieval arm has adistal tip that allows for catching of the suture in one preferentialdirection. The suture retrieval arm 313 may be advanced in a pistonmotion axially within the shaft of the plication deployment arm 313. Anembodiment of the suture (including a pre-tied sliding knot) ispre-loaded into the plication deployment device in the form of areloadable cartridge 315. The pre-tied sling knot can be loaded into theproximal spike of the phalange 314, and the positioning of the knotensures that the suture retrieval arm passes through the loop of theknot when the arm is deployed. After the free end of the suture ishooked, the suture arm is retracted. The integrated instrument isremoved, leaving a horizontal mattress suture 314 at the base of thecapsular pleat. The sliding knot is tightened by pulling the free end ofthe suture, as shown in FIG. 5E. Various embodiments can use eitherresorbable or non-resorbable suture types as well as varying suturesizes. In addition, instead of sliding knots, anchors (not shown) thatpass over the suture ends and prevent retraction of the suture can beadvanced over the suture ends until the knot is secured.

An alternate embodiment includes the phalange spikes having a pre-loadedU-shaped short suture segment whose ends are attached to elastic barbs.The opposite phalange is pre-loaded with a short suture segment withrigid rings attached at both ends. The orifices of the non-spikedphalange dictate the position of the two suture rings. When the jaws ofthe plication deployment device are closed, the two barbs deploy intotheir two respective rings. This creates a closed ring of suture (in ahorizontal mattress pattern) through the base of the capsular pleat.

FIG. 6 depicts a series of exemplary steps that may be used to repair orplication tissue 601 using a repair deployment device 610 according tothe present invention. After advancing the repair deployment device 610to the region of interest, the grasper mechanism 611 is deployed. Thegrasper is advanced beyond the jaws of the device, as shown in FIG. 3,and the cantilevered arms of the grasper engages the tissue 602, asshown in FIG. 6. The grasper 611 is then retracted, forming a tissuepleat 602 as it is drawn into the jaws of the repair deployment device610.

In the exemplary embodiment shown, the jaws of the device 610 open asthe grasper is retracted 611. In other embodiments, the jaws may bemanipulated independently to the grasper mechanisms from the proximalhandle of the device. The retracted grasper draws the tissue pleat 602into position within the jaws of the device. As mentioned in theembodiment described in FIG. 4, the amount of plication or tightening ofthe capsule is a function of the amount of pleat that is drawn into thejaws, which is controlled by the position of the grasper. Once thetissue pleat is in position, the jaws of the repair deployment deviceare engaged.

In the embodiment shown, there may be one, two or more hollowpenetrating spikes positioned in a horizontal or vertical position atthe distal tip of the device, such as shown in FIG. 3 and FIG. 7. Uponengaging of the jaws, these spikes will penetrate the tissue pleat.Similar to the mechanism described in FIG. 5, a preloaded suture 612with a pre-tied sliding knot, extending through the suture grasper 620and anchored to a suture grasper 630, can be loaded into the spikes. Asuture retrieval arm is advanced along the jaw of the deployment deviceand as previously described can engage the suture. After the free end ofthe suture is hooked, the suture arm is retracted. The integratedinstrument is removed, leaving a horizontal mattress suture 631 at thebase of the capsular pleat. The sliding knot is tightened and locked bypulling the free end of the suture and advancing the knot. Variousembodiments can use either resorbable or non-resorbable suture types aswell as varying suture sizes.

FIG. 7 depicts another exemplary embodiment 710 of the suture clip witha grasper 711 engaging tissue 701 with a suture 712 anchored suppliedthrough a suture grasper 730. Shown in this example is a suture elementwith both ends having spikes or needles that allow for loading into therepair deployment device distal tip and deployment through the capsuletissue upon engagement of the jaws, as described in the previousembodiments. In this embodiment, the dual spiked suture clip is passedthrough the tissue pleat 702 from phalange to phalange. The ends areretrieved and standard sliding knots are tightened and locked by pullingthe free end 733 of the suture and advancing the knot.

FIG. 8 shows another exemplary embodiment of a suture clip and repairdeployment device 810 wherein the suture 812 or clip material is loadedinto a non-spiked phalange 811. In this embodiment, the spiked ends ofthe opposite phalange will engage the suture or clip material when fulljaw engagement is performed. As a result, the spikes will penetrate thetissue pleat 802 then engage the suture 812 or clip material. Opening ofthe jaw will result in the suture or clip material to be withdrawn withthe spiked phalange, pulling the material through the tissue pleat. Thedevice would then be withdrawn. The suture slack 818 and ends areretrieved and standard sliding knots are tightened and locked by pullingthe free end of the suture and advancing the knot.

The exemplary embodiment shown in FIG. 9 shows another suture clipaccording to the present invention. Similar to the previously describedsystems of FIGS. 3 to 8, the embodiment here utilizes the same graspingmechanisms to generate the tissue pleat 902 and pull the pleat withinthe jaws of the repair deployment device 910. The difference in thisembodiment is the use of a suture clip 940 or a U-shaped clip that canbe loaded into the distal end of the spiked jaws. In this case, thespikes can be a characteristic of the jaws or a characteristic of thedistal tips of the suture clip or U-shaped clip devices. In either case,the purpose of the spiked ends is to penetrate the tissue pleat. On theopposite jaw, a locking base is loaded to mate with the suture clip orU-shaped clip. Once the grasper mechanism has been deployed and thetissue pleat is in position within the jaws of the repair deploymentdevice, the jaws can be engaged. Engagement of the jaws results in thesuture clip or U-shaped clip to penetrate the tissue pleat and lock intothe base on the opposite phalange. The locking of the clip into the basethen does not require knot tying, but rather a firm repair of the tissuepleat is generated. The pleat is then released from the grasper andplication deployment device withdrawn.

In the exemplary embodiment shown in FIGS. 10A to 10D and FIGS. 11A to11H, a repair deployment device 1000 is shown without and with a clipdevice 1030 at the distal tip of the device jaw, respectively. Theproximal end of the deployment device 1000 is not shown for sake ofsimplicity. Note that the proximal handle of the device will allow foractuation of the distal tip jaws as well as manipulation of the graspermechanism. This actuation can be independently controlled orinterconnected so a single handle actuates both mechanisms, similar tothe handle shown in FIG. 4F.

The overall dimensions of the deployment shaft for device 1000 includethe ability to be delivered through a 5 to 8 mm arthroscopic cannula. Inaddition, embodiments of the proximal end of the device can include arotational translating mechanism associated with the shaft, allowing foradjustment in the rotational alignment of the shaft and hence the jawswith respect to the actuating handle. This rotational adjustment can belocated at or adjacent to the pivot point of the jaws to the shaft, oralong the shaft.

Alternatively, the shaft can be fabricated from a shape memory alloyconfigured to exhibit martensitic properties at the operationaltemperatures (e.g., 37 degrees Celsius). Therefore, the shaft can bebent into the desired curve, along with the inner cabling components.After the procedure, the device may be heated above the austenitictransformation temperature such that the instrument returns to itsmemory straight position. A primary purpose of changing the jawactuation axis versus the handle axis is to allow the user to change theangle or position of the jaws relative to the ligament tissue withoutrequiring the user to perform macroscopic manipulate the actuatinghandle, which is confined by the cannula and access point into theworking cavity. In addition, a ratcheting rotating mechanism forpositioning of the device shaft over up to 360 degrees enables lockingthe device shaft at a specified rotational position to the handle so theoperator can access more capsular locations than would be available witha rigid straight shaft. The instrument shaft can alternatively befabricated with a curve or bend, the instrument can be fabricated from amalleable alloy that doesn't exhibit shape memory properties providedthe permanent bends do not affect the fatigue lifecycle of theinstrument or render it aesthetically inadequate.

In practice, various clip device embodiments (see clip designembodiments) could be implemented at the distal tip of the device jaws.The centerline grasper embodiment has variations (see grasperembodiments). In the grasper embodiment shown, the deflection of thegrasper is inherent in the design. The grasper may be constructed ofmaterial(s) that allow for elastic deformation of the arm elements(e.g., super-elastic materials such as Nitinol, stainless steel, 17-7,stainless steel 304, stainless steel 316, or other biocompatiblestainless steel, other alloy, aluminum, superelastic polymers, sinteredmetals, machined metals, carbon fiber, gas impregnated nylon,polycarbonate, ABS, other polymers, or insert molded compositematerials).

The end of the grasper may be pre-shaped into the open position, openingto an angle from 0 to 90 degrees. The distal tip length of the grasper(which is deformed to a predetermined opening angle) may range, from,for example, from 1 to 50 mm in length. The grasper may be positioned ina central lumen of the deployment device. As shown in the figures, theupper and lower jaws of the deployment device may have tapered channelsor guiding channels in which the undeployed grasper arms can sit duringthe initial advancement of the deployment device through thearthroscopic cannula. Furthermore, the shape of these channels aid inthe guiding of the deployed grasper back into the jaws. Note the spacingbetween jaws allows room for both the clip device at the distal tip aswell as the thickness of tissue drawing into the jaws with the grasper.The capsular tissue thickness varies between 1 and 7 mm.

Upon deployment (e.g., forward push out) of the centerline grasper, thespecified angular deformation of the grasper tip will open up the arms1010 because they are no longer constrained by the centerline channel.Pull back of the centerline grasper will result in closing of the clampsand pull back of a specified segment 1101 of tissue 1100 into the jawsof the deployment device. The level of plication will depend on thedistance at which the grasper arms are drawn into the deployment device.The range of plication distance for capsular plication application istypically between 1 and 25 mm, more specifically between 2 and 10 mm.More or less tissue plication can be chosen by adjustment in theposition of the grasper arms. The length of tissue plicated (e.g.,plication distance), depending on the application and extent of thecapsular laxity, will typically range between 1 and 50 mm; morespecifically between 5 and 20 mm. It should be noted that for this andother non-capsular plication applications, the plication distance can begreater than 25 mm, depending on the application and soft tissuecharacteristics. The amount of tissue plication can be chosen byadjusting the position of the grasper arms relative to the plicationclamp jaws. Force gauges can be connected to the grasper to measure thetension placed on the capsule during plication.

Alternatively, springs (static or adjustable) can be connected to thegrasper to direct a specified amount of tension applied to the capsuleby the grasper thereby producing a specific amount of tissue plication.In addition, axial distance of grasper movement relative to theplication clamp can be regulated to control the amount of plication asdetermined by distance as opposed to tension as described above.

The actuation of the jaws 1010 and grasper deployment 1020 can be linkedor can be independent in motion. The benefit of individual independentmotion is augmentation in clamping that the jaws can provide with thisembodiment of grasping. In other embodiments, the benefit of independentmotion may not demonstrate this distinct advantage. The mechanism ofactuation of the deployment device jaws includes both forward andbackward linkage actuation by simple linear motion from the actuatinghandle. The arrangement of the hinge linkage allow for considerableforce generation at the distal tip of the deployment device. Moreover,the simplicity in design provides a relatively problem free hingemechanism that can be cleaned easily. The shaft of the deployment deviceis made to have characteristics that allow for easy insertion though thearthroscopic cannula and no clinically relevant abrasion to thesurrounding soft tissues.

Once the tissue has been drawn into space between the jaws of thedeployment device and the grasper position is locked, the jaws of thedeployment device can be fully actuated, engaging the tissue foldbetween the ends of the plication clip, as shown in FIG. 11F. Theexemplary clip device 1300 shown in this embodiment is a two-piecedevice with the penetrating component held in the upper jaw and the baseor locking component held in the lower jaw. The individual componentsare held into position at the distal tip of the jaw either using asnap-fit or mechanical locking mechanism that can be released by simpleactuation at the proximal handle. The penetrating component has two armsthat are tapered to allow for easy penetration through the soft tissueto be plicated. By fully engaging the deployment device jaws, thetwo-piece clip device will lock into position, plicating the tissuetogether. The clip device is then released from the deployment deviceand deployment device withdrawn from the site. The deployment device canbe reloaded with an additional clip device and subsequent plicationperformed using the methods described above.

The exemplary clip shown in FIG. 11 shows the plication clip orientedperpendicular to the axis of the plication clamp such that thepenetration sites of the clip are parallel to the capsule plane. Itshould be noted that the plication clip can alternatively be orientedalong the plication clamp axis such that the penetration sites areperpendicular to the capsular plane and are oriented vertical along theplicated tissue fold. Further, the plication clamp jaws can be curved(or rotatable as described above) and the plication clip oriented alongthis curved axis such that the penetration sites are located parallel tothe capsule plane. The plication clip embodiment in FIG. 11 is shownwith two clip penetration sites through the folded tissue. It should benoted that as few as a single penetration site and up to as many as 6 ormore penetration sites can be incorporated into a single plication clip.Similarly, in FIG. 23 an alternative embodiment is shown with adifferent grasping mechanism 2330, but with plication clips 2311oriented perpendicular to the axis of the plication clamp. FIG. 24 showsa variation in the distal tip embodiment with the plication clipembedded in the jaws of the device. Dimensions of the device shown inFIG. 24 will accommodate the dimensions required for clinical devicedelivery and tissue fold plication.

FIGS. 11A to 11H show an exemplary plication clip supported at thedistal tip of the deployment jaws. It should be noted that variousone-piece and two-piece clip device embodiments can be used to plicatethe soft tissue and are described in the subsequent Figure descriptions.Moreover, although FIGS. 10 and 11 depict the centerline grasper havingtwo arms, various embodiments may have additional arms or even as few asone arm. The various embodiments for grasping tissue and pulling thetissues into the deployment device jaws are described in subsequentFigure descriptions. It is important to note that in some instances thecenterline grasping mechanism is not the ideal orientation andoff-center grasping methods are preferred. In such instances, most ofthe described grasping embodiments can be adapted to off-center graspingpositions. For example, in the instance where one of the jaws of thedeployment device is stationary, an off-center grasping mechanism, withrespect to the jaws may be required.

The deployment device shown in FIGS. 10 and 11 shows an embodiment withtwo articulating jaws, in some embodiments only one articulating jaw maybe desirable. In the single articulating jaw instances, either the upperor low jaw will be fixed, while the opposing jaw will have the abilityto pivot into the open and closed position (See, for example, FIGS. 16and 17).

The exemplary deployment device embodiment shown in FIG. 12 shows thedistal jaws of the device and in some aspects is similar to thatdescribed with respect to FIG. 8. However in this embodiment the suturetips 1212 (which are the penetrating spikes/needles) can be passedbetween jaws of the device by a locking mechanism located on theopposite jaw. The embodiment in FIG. 12 shows a single suture strand1220 with two suture tips 1221 and 1222 oriented at the ends of thestrands. It should be noted that from 1 to 6 or more suture tips may beutilized and located at any combination of suture ends or segmentslocated along the length of a complete suture strand. For example, threesuture tips can be incorporated with two located at the ends of thesuture and one at the mid-point between the ends of the suture.

The suture tip transfer mechanism incorporated in the plication clampjaws can comprise a simple lock-fit/snap fit (as shown in FIG. 12), orcan incorporate magnetic components that facilitate passing the suturetips from one clamp jaw to the other. For example, the receiving end ofthe jaws can be magnetized to attract the suture tip (eithercomplementary magnetized or fabricated from an appropriate metal oralloy) of the opposing side after the jaws have been engaged. Additionalembodiments can include receiving ends with bi-leaflet, tri-leaflet, orother multi-leaflet configurations that allow for a frictional lock ofthe suture tips to hold or capture the suture on the clamping jaw afterpassing through the tissue fold. These receiving slots can be positionedalong the jaw in various orientations and numbers. The slots can spanthe width of the jaw or have multiple slots in series and parallel alongthe jaw. Moreover, the edges of the leaflet coaption points can havestress-relieving edges to allow for expansion of the orifice to catchthe sutures. In the snap fit, frictional lock or magnetized scenarios,the suture ends would be withdrawn from the site along with the suturetips. The suture ends are retrieved and standard sliding knots aretightened and locked by pulling the free end of the suture and advancingthe knot. Alternatively, anchors can be passed over the suture ends toeliminate the need for manually creating and passing knots. In the caseof multiple suture tips, the discrete suture ends associated with eachtip can be tied together or individually tied to create the desiredattachment of the plication.

In the embodiment shown in FIG. 12 the phalanges of the jaws areintended to aid in the agitation of the synovium. Variations of theseembodiments include roughed surfaces (e.g., rasp) and spikes 1211 withvariable sizes for penetration. These embodiments may be static or canalso be actuated both in the open or closed position of the jaws. In oneinstance, as tissue is withdrawing into the jaws using the graspingmechanism, the tissue would rub along the roughened embodiments or bepulled passed the roughened embodiments to irritate the synovium. In aninstance where the roughened surface is actuated, after engagement withthe jaws of the device, the phalange roughened area can move relative tothe surrounding jaw, resulting in a localized irritation of thesynovium.

More specifically, as shown in FIG. 12, various embodiments of thedeployment device jaws can include mechanism for roughening, abrading,or penetrating the plicated tissue fold to elicit a biological healingresponse, as described previously. These embodiments can includemechanical methods such as sharpen needle points, blunt points, raspingelements, or elements which can produce the desired abrasion,roughening, or penetration to elicit the desired biological healingresponse. These embodiments can also include non-mechanical mechanismssuch as thermal, chemical, x-ray, electrical, ultrasonic, ultravioletlight, or microwave signal mechanisms to cause the localized tissuedamage to the synovium that would also elicit the biological healingresponse that is desired.

In the exemplary embodiment shown in FIGS. 13 and 14, the proceduralapplication of a hinged clip device is shown with and without the use ofa grasper 1311. The distal end of the deployment device 1300 is shown inFIG. 13 where in (A) a portion 1331 of the ligament tissue 1330 iscaptured by the grasper mechanism, in (B) pulled into the jaws of thedeployment device, in (C) penetrated by the clip device and plicated,and in (D) the deployment device removed. This embodiment is shown toexemplify the stepwise procedure in deploying one of the clip devices1320. For simplicity, the element for abrading, roughening, penetrating,or exciting the biological healing response of the synovium are notshown, but may be similar to that shown in FIG. 12.

In some embodiments, a surgeon may agitate the synovium with a generalrasping arthroscopic instrument in the region of interest prior topositioning of the deployment device and deployment of the plicationclip. Furthermore, unlike the embodiment shown in FIGS. 10 and 11, theplacement of the clip device is positioned along the jaws of thedeployment device, not specifically at the distal tip. The advantage ofthe placement of this device in this position along the jaw of thedeployment device can be appreciated in FIG. 14 where the embodimentshown does not utilize a grasper to draw the tissue into the jaws of thedeployment device. In various embodiments of the clip device, hinged orpivoted actuation of the clip may allow for plication of the ligament orsoft tissue without the need of the grasper to bring the tissue intoposition.

In FIGS. 13 and 14 the clip device is snapped into its lockedconfiguration, clip released, and deployment device removed. In FIG. 13the level of plication would be dictated by position (e.g., pull back)of the grasping mechanism. With this hinged embodiment, the limitationto the plication length will be limited to the size of the clip design.Specifically, as shown in FIG. 13D, the clip device will surround thearea of plication. Noting that in the embodiment shown, the centerlinegrasper and the jaws of the deployment device may be off-set from eachother. Specifically, certain embodiments, if within the jaws of thedeployment device, may require the grasper to be stacked either adjacentof the jaws or on one side of the jaws (non-center).

As shown in FIGS. 13 and 14, there may be instances where the generalcapsular volume or excessive laxity will allow for plication of thetissue fold without the need for a grasper to bring the tissues intoposition. In such instances a simplified plication deployment device mayprove to be advantageous. However, it is anticipated that the advantagegained with respect to adjustment in the length of plication, alignmentand drawing of the tissue into the deployment device jaws may dictatethe need for a grasping mechanism. As indicated previously, the lengthof plication of this hinged embodiment will be limited to the size ofthe clip device. However, other embodiments (as described elsewhere inthis disclosure) will not have these sizing limitations. The primaryemphasis of FIG. 14 is to demonstrate that the clip designs themselvescan act as jaws that can grasp tissue without the need of a dedicatedgrasping mechanism.

The embodiment shown in FIG. 15 shows the use of neuro-stimulation as averification tool indicating the proximity of neurovascular structures,in particular the axillary nerve 1540. Similar neuro-stimulationapplication can be applied to some of the exemplary embodiments, forexample the devices shown in FIGS. 23-33. Hence, the delivery and sutureplication devices shown in FIGS. 23-33 can contain a centralized ornon-centralized grasping element that can carry the neuro-stimulatingsignal to allow for verification of the proximity of neurovascularstructures, in particular the axillary nerve. As discussed earlier, theposition of the axillary nerve relative to the inferior capsule iswithin approximately 1 cm. The close proximity of this nerve raisesconcerns when applying any plication method to the capsule. An exemplaryembodiment of the deployment device includes the incorporation of aneuro-stimulation probe to excite the region of plication prior toengagement of the plication clip. The probe element can comprise eitherthe grasping mechanism and/or the deployment device jaw. An externalenergy source capable of delivering pacing stimuli having an amplitudefrom 0.1 mA to 50 mA is connected to the probe element 1550 andstimulator/detector 1560 (e.g., the grasper, plication clamp jaws, orindependent electrode probe) to transmit the electrical stimulation tothe capsular tissue in direct proximity to the grasper and/or plicationclamp.

Activation of the axillary nerve 1540 (or other nerve or muscle tissue)would be caused if the grasper or plication clamp jaw is too close tothe axillary nerve (or other nerve or muscle tissue). Activated responsewould be observed by twitching of muscles associated with theneurovascular structure. For example, activation of the axillary nervewill result in a muscle response from the deltoid muscles. The intendedneuro-stimulation is intended to provide minimal excitation forpositional identification only, not for diagnostic or treatmentpurposes.

Stimulation of the axillary nerve (or other nerve or muscle tissue)provides a clear warning that the grasper and/or plication clamp jawsare at risk of damaging the axillary nerve and indicates the physicianshould move the plication device to another location, thereby avoidingunwanted nerve (or muscle) damage.

Commercially available stimulators can be utilized to delivery the 0.1mA to 50 mA pacing pulse. The waveform can be monophasic, biphasic, orother pattern known to evoke stimulation of nerve or muscle tissue. Thepulse duration can vary between 1 msec to 500 msec. The amplitudedetermines the proximity of the probe element to the stimulated nerve ormuscle. For example, a plication device that stimulates the axillarynerve by delivering a biphasic pacing pulse having a duration of 10 msecand an amplitude of 1 mA is closer to the axillary nerve than aplication device that requires 10 mA to stimulate the axillary nervewith the waveform and duration being the same. As such, the proximity ofthe axillary nerve can be determined by the amplitude of the pacingpulse thereby ensuring that plication does not damage the axillary nerve(or other nerve or muscle), and/or mapping the location of the axillarynerve to plan the location of tissue placations.

Although the exemplary embodiment of the invention as shown in FIG. 15is described with respect to the shoulder capsule and the axillarynerve, one having ordinary skill in the art would be cognizant that thesame technique may be applied to other tissues or tissue systems havingother nerves passing therethrough.

The exemplary embodiments shown in FIGS. 16 and 17 illustrate a devicethat has a grasper mechanism 1631, a suture retrieving mechanism 1641,and a jaw mechanism 1610. This device configuration has a hinged distaljaw 1610 with one jaw 1620 in a fixed configuration. Similar topreviously described grasper mechanisms, this single armed grasper isshown in a deformed configuration, but can also be oriented into anyangular position (including a straight configuration) by pre-deformingthe grasper shaft. The grasper embodiment shown includes two primarycomponents: an exterior guiding tube 1630 and an interior deploymentanchor 1631. The anchor 1631 begins within the guiding tube sheet in anundeployed/low profile configuration. The distal tip of the anchor 1631is tapered to allow for penetration through soft tissue layers. Thesurface of the guiding tube 1630 is smooth or can be lubricated orcoated (e.g., hydrophilic coatings) to allow for easy penetration andpassage through tissues.

The guiding tube 1631 can be advanced beyond the jaws as illustrated inFIG. 17A. After penetration of the anchor 1631 and guiding tube throughthe tissue layers 1650, deployment/advancement of the anchor andsubsequently deployment of the anchor wings (to prevent pull out) isperformed. Once anchor 1631 is fully deployed, the grasping mechanism isdrawn back into the jaw of the device, pulling a tissue fold 1651 intothe jaws. Once the grasping mechanism is withdrawn, the jaws areengaged. The suture retrieving mechanism also includes two components:an outer guiding tube 1640 and an inner suture grabber 1641. Duringengagement of the jaws, the outer guiding tube 1640 penetrates thefolded tissue 1651. Once fully engaged, the suture grabber 1641 isdeployed.

Once the suture is engaged, the jaws are released, and suture pulledthrough the tissue layers. The grasping mechanism may be maintained inposition or released depending on the surgeon's preference. In someinstances, the surgeon may elect to keep the grasping mechanism inposition to maintain the tissue pleat until final plication is finished.Repeated passing of the suture is performed and knots tied to secure theregion of plication. Coordinated movements of the jaws and deployment ofthe suture grabber add to the simplicity of the device embodiment.Various embodiments can be included in the jaws of this deploymentdevice embodiment to accommodate the use of clip devices at the distaltip, as exemplified in FIGS. 10 and 11.

The anchor wings may be made from metals, shape memory metals, polymersand shape memory polymers that can be deployed and retraced into theguiding tube. The shape of the wing deployment can vary (e.g.,elliptical, spherical, triangular, corkscrew, hook). The primary purposeof the wing shape is to provide an anchoring point to pull the tissueinto the grasper. Other embodiments of the anchor deployment may alsoinclude inflation of balloon anchors of various configurations andmaterials (e.g., silicone, polyurethane, PET, Nylon, etc.). An advantageof the single armed grasping embodiment is the ability to leave thedevice engaged while releasing and rotating the overall device. Thismotion is allowable because of the wing shape or balloon tip anchoringmechanism, which is does not actively grasp the tissue as shown in FIGS.10 and 11.

An embodiment of the deployment device has a total length (including theactuating handle) to be about 20-100 cm with the shaft of the devicebeing about 12-92 cm of the length. The range in maximal width ormaximum diameter of the shaft and working end of the device will rangebetween 4.0 to 8.0 mm. The length of the deployment device jaws willrange from 10 to 40 mm in length.

Grasper embodiments 1800 and 1900 shown in FIGS. 18 and 19 depictvariations of the grasping mechanism described for other embodiments,such as those shown in FIGS. 3 and 4. Engaged and unengagedillustrations are shown for two pronged and three pronged embodiments.As indicated in the figures, the ends 1810 and 1910 of the grasperembodiment can include tips 1820 and 1920 that are triangular in shapeor another similar tooth-like structure that would allow for gripping orengaging of soft tissues when engaged. These tips could also includereverse hook configurations (similar shape to knitting needles).Additional embodiments that include additional prongs can also beincluded as well as an embodiment containing only one arm. The singlearmed embodiment will include a similar distal tip that can hook andengage soft tissues, allowing for grasping and drawing of the deviceinto the jaws of the deployment device.

Grasper embodiments 2000, 2100 and 2200 shown in FIGS. 20, 21 and 22depict variations of a single armed grasping mechanism using ananchoring system. In addition to the embodiment described in FIGS. 16and 17, the embodiments shown in FIGS. 20, 21, and 22 show a method forgrasping tissue using a deployed anchoring system. In FIG. 20 theundeployed grasper is held within the guiding tube. The distal tips2010, 2110 and 2210 of the grasper embodiments are a tapered orsharpened point that allow for tissue penetration. The shaft of theguiding tube as well as the grasper device are polished or coated toallow for easy passage through tissues. The diameter size of thesedevices can range from 0.5 to 3.0 mm. Once the grasper penetrates thetissue layers, the grasper is advanced beyond the guiding tube to allowfor deployment of the anchor. The embodiments shown are hook andcorkscrew configurations; however, the shape and deployment can vary asdescribed for FIGS. 16 and 17. The materials used to accommodate thesedistal configuration changes can include shape memory metals/polymers orother specified metals or polymer materials. An advantage of theseembodiments is the ability to adjust the shape to make the device morecompatible with surrounding structures (e.g., axillary nerve) as well asimprove the ability to adequately grasp the tissue and pull the tissueinto the jaws of the deployment device.

Alternative graspers include balloons incorporated at the distal tip ofa central tube that can be expanded once positioned through or into thecapsular tissue. The balloon can be oriented proximal to a needle or canincorporate a central lumen such that a separate needle can pass.Alternatively, a tube coupled to a vacuum source can be used as thegrasper such that as suction is applied through the tube the tissue ispulled into engagement with the tube and can be manipulated by thevacuum grasper. To augment the vacuum grasper, a flexible flange can beincorporated to enlarge the vacuum orifice and better secure the vacuumgrasper to the tissue surface. This flange can solely comprise aflexible silicone or polyurethane membrane (or other flexible polymer)or can incorporate strips of support material formed in an outwardfashion and covered by a flexible membrane. The strips expand theflexible membrane outward as they are released from the confines of theguiding tubes and compress the flexible membrane as they are retractedinto the guiding tubes. The enlarged opening increases the surface areaof tissue that is contacted by the vacuum grasper increasing thegrasping force.

The grasper embodiments shown can be connected to an external simulatorfor neuro-stimulation to verify the location and position of theplication relative to neurovascular structures (e.g., axillary nerve),in a similar way as that shown for FIG. 15. Once the plication has beeneffected, the grasper anchor is released from engagement to the plicatedtissue and is drawn back into the guiding tube. The low profile andsimplicity of deploying these anchors to grasp tissue provides amechanism that is reproducible, can have a secondary function ofirritating the synovium (eliciting a biological healing response) bypenetrating the tissue layer in local proximity to the plication, andprovide a sturdy anchoring system that the surgeon can pull back thetissue pleat into the jaws of the deployment device.

Grasper embodiment 2300 shown in FIG. 23 depicts a variation in thegrasping mechanism with an outer sleeve in which an inner element with apre-shaped distal tip 2330 is located. The purpose of the pre-shapeddistal tip is that it can be drawn by shaft 2320 into the outer sleeveto close the jaws 2310 of the grasper. This mechanism provides theability to advance and withdraw the grasper independent of the closingof the jaws.

In FIG. 23 an alternative embodiment is shown with a grasping mechanismwith plication clips 2311 oriented perpendicular to the axis of theplication clamp. FIG. 24 shows a variation in the distal tip embodimentwith the plication clip 2411 embedded in the jaws of the device.Dimensions of the device shown in FIG. 43 will accommodate thedimensions required for clinical device delivery and tissue foldplication.

FIGS. 25A to 25C and FIG. 26 show exemplary embodiments 2500 and 2600 ofa distal tip of a suture delivery device intended for the same purposesand functions as described for the embodiments in FIGS. 4-9. Thegrasping embodiment shown in FIG. 26 can be substituted with any of thegrasping embodiments presented within this disclosure. The penetratingsuture elements can be one or greater in number. In FIGS. 25 and 26, twosuture penetrating elements are shown as 2511 and 2611 within jaws 2510and 2610. In these embodiments the suture is held on one side of the jawand the penetrating elements on the opposite jaw. The suture side holdsthe suture in a manner that allows for engagement of the penetratingelements to catch the suture and during engagement and pull the sutureback through the tissue fold when released. The suture can be freelyadvanced through the tissue fold during withdrawal of the device. Itshould be noted that 1 to, for example, 6 suture tips oriented at theends of the strands and located at any combination of suture ends orsegments located along the length of the complete suture strand. Forexample, three suture tips can be incorporated with two located at theends of the suture and one at the mid-point between the ends of thesuture. The suture side of the jaw can be removable and replaceable foruse as a cartridge for additional sutures.

In various embodiments, different suture lengths can be incorporated toallow for delivery of one or more suture plications. The penetratingsuture tips can have a variety of embodiments that allow for catching ofthe suture. As shown in FIG. 26, the penetrating element 2611 can have ahook edge along the axis that allow for capture of the suture as itpasses through the suture holding side of the jaw. The shape andgeometry of the hook edge is inverted as to minimize the potential forcatching on tissue during the withdrawal of the penetrating elementswhile enabling capture of the suture for withdrawal. Additionalembodiments of these suture tips can include variations that haveflexible latches that cover the hook edge and allow for capture of thesuture as well as securing of the suture while providing a smoothtransition along the penetrating element axis (reducing the potentialfor catching of the tissue during withdrawal). Other embodiments caninclude deeper and more curved J-hooked edges that have smooth edges andallow for capture of the suture while reducing the possibility of tissuecatching during withdrawal. Once the suture end is captured andretrieved, standard sliding knots are tightened and locked by pullingthe free end of the suture and advancing the knot. Alternatively,anchors can be passed over the suture ends to eliminate the need formanually creating and passing knots.

Similar to previously described embodiments, the jaws of the device canalso incorporate roughed surfaces (e.g., rasp) and spikes with variablesizes for penetration. These embodiments may be static or can also beactuated both in the open or closed position of the jaws. In oneinstance, as tissue is withdrawing into the jaws using the graspingmechanism, the tissue would rub along the roughened embodiments or bepulled passed the roughened embodiments to irritate the synovium. Inanother instance, after engagement of the jaws, the device willpenetrate the tissue, resulting in localized irritation of the synoviumalong distinct roughened or spiked locations along the flange of thejaw.

In addition, similar to that described for the embodiment shown in FIG.15, neuro-stimulation can be added to these device tips either throughthe grasping mechanism or through the penetrating elements. The primarypurpose would be for verification of the proximity of neurovascularstructures, in particular the axillary nerve.

FIGS. 27-31 show various alternative embodiments of the distal tip of asuture plication delivery device. As shown, single or multiple suturescan be passed at the device tip in various orientations. Not shown, butincluded in these embodiments is a central or non-central graspingmechanism. Any of the grasping mechanisms described for the devices inthis document can be utilized in this embodiment. Similarly, asdescribed for the embodiment shown in FIG. 15, neuro-stimulation can beadded to these device tips either through the grasping mechanism orthrough the penetrating elements. A primary purpose would be forverification of the proximity of neurovascular structures, in particularthe axillary nerve.

A purpose of presenting FIGS. 27-31 is to demonstrate variousnon-limiting distal tip embodiments for suture passing where one side ofthe jaw holds the suture and the opposite side has the penetrating andsuture capture element. Similar to that described in FIGS. 25 and 26,the suture side holds the suture in a manner that allows for engagementof the penetrating elements to catch the suture and during engagementand pull the suture back through the tissue fold when released. Thesuture can be freely advanced through the tissue fold during withdrawalof the device. It should be noted that 1 to, for example, 6 suture tipsmay be oriented at the ends of the strands and located at anycombination of suture ends or segments located along the length of thecomplete suture strand. For example, three suture tips can beincorporated with two located at the ends of the suture and one at themid-point between the ends of the suture.

The suture side of the jaw can be removable and replaceable for use as acartridge for additional sutures. In various embodiments, differentsuture lengths can be incorporated to allow for delivery of one or moresuture plications. The penetrating suture tips can have a variety ofembodiments that allow for catching of the suture. As shown in FIG.27-31, the penetrating element can have a hook edge along the axis thatallow for capture of the suture as it passes through the suture holdingside of the jaw. The shape and geometry of the hook edge is inverted asto minimize the potential for catching on tissue during the withdrawalof the penetrating elements while enabling capture of the suture forwithdrawal. Additional embodiments of these suture tips can includevariations that have flexible latches that cover the hook edge and allowfor capture of the suture as well as securing of the suture whileproviding a smooth transition along the penetrating element axis(reducing the potential for catching of the tissue during withdrawal).Other embodiments can include deeper and more curved J-hooked edges thathave smooth edges and allow for capture of the suture while reducing thepossibility of tissue catching during withdrawal. Once the suture end iscaptured and retrieved, standard sliding knots are tightened and lockedby pulling the free end of the suture and advancing the knot.Alternatively, anchors can be passed over the suture ends to eliminatethe need for manually creating and passing knots.

An additional element shown with the exemplary embodiments in FIGS.27-31 is a flexible cantilever, flexible bow, or guard on thepenetrating element flange that allows the opposing flange to restwithout engagement of the suture and the penetrating element. In thisresting position, the device can be introduced through a standard 5, 6,or 8 mm cannula without engagement.

Various embodiments show that different shapes and configuration withvariable numbers of penetrating elements and position of penetratingelements can be chosen and not limited to those shown in FIGS. 27-31. Acommon element of these embodiments is the ability to engage the sutureand penetrating element by further engaging the jaws. The additionalengagement, achieved by closing the jaws by applying additionalpressure, will result in deformation, bending, or shifting of thecantilever, flexible bow, or guard to expose the penetrating element.The exposure of the penetrating element allows for penetration ofthrough the tissue fold and engagement of the element with the suture.The subsequent opening of the jaw results in pulling of the suture backthrough the tissue fold and return of the cantilever, flexible bow, orguard to its original position.

Similar to previously described embodiments, the jaws of the device canalso incorporate roughed surfaces (e.g., rasp) and spikes with variablesizes for penetration. These embodiments may be static or can also beactuated both in the open or closed position of the jaws. For example,as tissue is withdrawing into the jaws using the grasping mechanism, thetissue would rub along the roughened embodiments or be pulled passed theroughened embodiments to irritate the synovium. In another example,after engagement of the jaws, the device will penetrate the tissue,resulting in localized irritation of the synovium along distinctroughened or spiked locations along the flange of the jaw.

In addition, similar to that described for the embodiment shown in FIG.15, neuro-stimulation can be added to these device tips either throughthe grasping mechanism or through the penetrating elements. A primarypurpose would be for verification of the proximity of neurovascularstructures, in particular the axillary nerve.

The exemplary embodiment in FIG. 32 shows a repair device 3200 having aflexible shaft to allow for insertion, movement and manipulation throughcontoured body geometry to access the necessary target tissue. Aninternal slide mechanism 3230 allows for manual or automatedmanipulation of the jaws 3210 to allow the gripper 3220 to pierce thepenetrating point 3221 into the target tissue. An abraded surface and/orneuro-stimulator may also be added to this exemplary embodiment toenhance the tissue repair process and nerve avoidance, respectively.

FIG. 33 illustrates another exemplary embodiment of the delivery devicein which the plicating suture or clip is delivered over the outside ofthe device shaft. In this embodiment, the tissue 3330 is grabbed to formthe tissue fold 3331. Then the plication suture or clip is advanced downthe shaft of the device. Once in position, the tissue is released. Thesuture element can be a pre-tied embodiment or an elastic bandembodiment. The plication clip can be of the forms shown in FIGS. 43 and44.

Various plication devices were disclosed by example within the exemplaryembodiments described above. Such plication devices may have a number ofdifferent shapes and sizes, which are all within the scope of thepresent disclosure. Various specific shapes and sizes will be discussedherein but the present invention is not limited to such exemplaryembodiments.

The exemplary embodiment shown in FIG. 34 depicts a plication clipdevice that includes a penetrating base 3410 and a locking base 3420.The overall device shown is circular in cross-section as an example.However this cross section could also be square, rectangular,triangular, or any other geometric cross-section. The penetrating base3410 of the clip device has a distal tip that is sharpened or tapered toallow for easy passage through tissue 3440. Just below the distal tipare multiple protruding tapered, outwardly extending locking elementsthat mate with corresponding holes 3421 on the locking base 3420. Thenumber of locking elements can range from 1 to, for example, 6. Whenengaged together, the plication clip locks into position, securing thetissue pleat 3441. This embodiment or variation can be delivered throughplication clamps described above.

The embodiment shown in FIG. 35 depicts a two-component plication clipsystem having a dual arm penetrating tubular U-shaped component 3510 anda locking base 3520. Both ends of the penetrating component are taperedto allow for easy penetration through soft tissue. In addition, lockingtabs are positioned at the distal tips and extend outward for mating andsecuring of the U-shaped component to the locking base. The locking base3520 has two sets of through-holes 3521 for the U-shaped component toengage and lock to the base. The bottom set of through-holes are smallerin diameter to allow for seating of the distal tips of the U-shapedcomponent, but does not allow the device to slip through. The width ofthe device can range from 2 to 30 mm; and more specifically from 2 to 10mm. The height of the device can range from 2 to 20 mm; and morespecifically 2 to 6 mm. The thickness of the device clip members canrange from 0.25 mm to 3 mm.

The embodiment shown in FIG. 36 depicts a three-component plication clipsystem: a dual arm penetrating tubular U-shaped component 3610, an outercovering for the U-shaped component 3611, and a locking base 3620. Bothends of the penetrating component are tapered to allow for easypenetration through soft tissue. The locking tabs are positioned at thedistal tips for mating and securing of the U-shaped component to thelocking base. These locking tabs are tapered to allow for easy slidinginto the holes 3621 of the locking base. The locking base has two setsof through-holes 3621 for the U-shaped component to engage and lock withthe base. The holes in the locking base have tapered and shaped holes,such as the star shaped holes used in the figure, that allow for easyengagement of the lock mechanism. The bottom of the locking baseincludes through-holes for the U-shaped distal tips to seat, but doesnot allow the device to slip through the locking base.

The outer covering can be fabricated form a resorbable material or apolymer such as polypropylene or other suture materials to cover thecentral support that can be fabricated from a metal or alloy, or apolymer with sufficient structural properties to engage the locking baseand prevent release of the two components once engaged. The width of thedevice can range from 2 to 30 mm; more specifically from 2 to 10 mm. Theheight of the device can range from 2 to 20 mm; more specifically 2 to 6mm. The thickness of the device components can range from 0.25 to 3 mm.

The embodiments 3710 and 3810 shown in FIGS. 37 and 38 depicttwo-component plication clip systems having a dual arm 3720/3721 and3820/3821 penetrating tubular U-shaped component and a dual arm tubularlocking base. Various embodiments of these devices can include circular,rectangular, square, or other geometric cross-sections. Both ends of thepenetrating component are tapered/sharpened to allow for easypenetration through soft tissue. Alternatively, one end can be bluntwhile the other end sharpened. The locking tabs, extending outwardly,are positioned near the distal tips for mating and securing of theU-shaped components to the locking bases. In each embodiment, thepenetrating component slides into the locking base arms and tabssecurely lock the devices together when engaged together.

The embodiment in FIG. 37 incorporates a rigid tab 3730 that extendsoutwardly with a locking component that incorporates a slot 3740 fromthe distal tip to the locking opening. This allows radial expansion ofthe base around the locking tab 3730 until the locking tab is situatedin the opening where the base returns to its original shape locking thetab within the opening. The embodiment in FIG. 37 can be fabricatedcompletely from polymers (e.g., polypropylene, other suture material, orother biocompatible polymer) since the tab of the base does not need todeflect and spring back to its preformed shape but can be rigid sincethe larger diameter lock expands during engagement of the twocomponents.

The embodiment in FIG. 38 incorporates an outwardly extending tab 3830to the clip base that engages an opening 3840 in the clip lock. As suchthe tab 3830 must deflect during insertion of the base into the lock andreturn to its original orientation once positioned within the opening ofthe lock to secure the base to the lock. As such, the tab mustincorporate enough spring such that the thin member can deflect andreturn once the confining forces are removed, commiserate with placingthe tabs into the opening of the clip lock. In this embodiment the basecan comprise a metal tube cut and formed into the illustrated shape orshort metal inserts that are insert molded inside a polymer to reducethe surface area and volume of metal incorporated in the device therebyreducing the radiopacity. Alternatively, the base can comprise a polymerwith sufficient thickness and rigidity to define a hinge over which thetab can flex and define enough of a spring constant to engage theopening of the clip lock once positioned into engagement.

The embodiments in FIGS. 37 and 38 penetrate both the base and lock intothe plicated tissue thereby reducing the height of each component (baseand lock) from the crossbar to the distal tip. As such, the profile ofthe clip on the deployment device is reduced and the locking point ispositioned within the plicated tissue. The width of the device can rangefrom 2 to 30 mm; more specifically 2 to 10 mm. The height of the devicecan range from 2 to 20 mm; more specifically 2 to 7 mm. The thickness ofthe device components can range from 0.25 to 3 mm.

FIG. 39 depicts an alternative embodiment that can be incorporated inany of the U-shaped components which have a multiple stage lockingmechanism. The purpose of the multiple stage locking mechanism is toprovide a method to increase the tightness of the plication. Althoughthis embodiment shows only two stages or components 3910 and 3920 oflocking, the number of locking stages or components can be increaseduntil full engagement or overlap of the cross bars is achieved.

Similarly, the embodiment shown in FIG. 41 shows a two-componentplication clip system with penetrating elements 4111 on each component4110. Opposing sides of the components have tapered penetratingcomponents 4111 to allow for easy penetration though soft tissue. Inaddition, locking tabs 4112 are positioned at the distal tips of thepenetrating elements for mating and securing of the U-shaped componentsto engage the opposing base. Two positions of locking are demonstratedin the illustrations; however in other embodiments the number ofpositions can be increased. Moreover, the distance between each lockingpoint is adjustable from 0.001 mm to 1.0 cm. A purpose of the multiplestage locking mechanism is to provide a method to increase the tightnessof the plication. The width of the device can range from 2 to 6 mm. Theheight of the device can range from 2 to 5 mm. The thickness of thedevice can range from 1 to 3 mm.

The exemplary embodiment shown in FIG. 40 presents a U-shaped plicationclip device with a hinge attachment 4030 that the device pivots around.The hinge is shown as a pivoting mechanism. Alternatively a flexiblehinge inherent to an integrated, unitary device can be utilized. One end4010 of the clip device has a distal tip that is tapered to allow fortissue penetration while the proximal end 4020 is bevel shaped to acceptthe distal tip. As shown, the distal tip 4010 of the device has alocking region 4040 that inserts and engages the proximal end. Otherembodiments of this clip can include variations on the hinge mechanism,variations in cross-sectional geometry (e.g., circular, rectangular,square and other geometric shapes), and variations in height, width, andlength of the device.

Another embodiment is shown in FIG. 42 as a U-shaped repair clip devicethat can be used with and without a pledget element 4220, shown in FIG.42C. In the deformed delivery position 4210, FIG. 42A, the clip devicecan be delivered through the tissue using an introducer deploymentmechanism (e.g., dual tapered needles) or tapering of the clip feet. Inthe undeformed position 4211, FIG. 42B, the clip device engages thetissue by deploying feet anchors 4213, as shown in FIG. 42F. Anotherembodiment of this includes the use of a backing or pledget component4220 that is used as the locking base of the clip device. The clipdevice would be deployed as above, however, the locking base would beused to insure adequate locking of the tissue. The locking base would besupported by one jaw of the plication clamp while the deformed clip isadvanced through the tissue and through openings in the locking basewith the second jaw of the plication clamp. Once positioned, the clip isreleased locking the clip into the base through the plicated tissue.

Additional embodiments of this device would include variations in thecross-sectional profile of the device (e.g., circular). This embodimentcan be deployed as shown in FIG. 42F, or through the base of theplication in a horizontal manner, similar to that depicted in FIG. 36for the U-shaped plication clip. The deployment shown in FIG. 42F is areverse plication where the fold is opposite to that of the accesssurface. The repair clip embodiment shown in FIG. 42A to 42F enableseither the reverse plication or original plication shown in FIG. 36.When executing a reverse plication, the capsule is not pulled into thejaws via a grasper. The locking ends of the clip are positioned at twopoints, separated by the clamp jaws, that are compressed together suchthat once positioned the released clip causes the plicated capsulartissue to fold in the opposite direction to the crossbar.

An alternative reverse plication clip embodiment 4310 is shown in FIG.43 where the centralized crossbar 4312 is made of a coiled shapedconfiguration that can act as a spring or the centralized crossbar couldalso be made of an elastic material. Deployment of the device would besimilar to that described for FIG. 42, including the use with pledget.The embodiment in FIG. 43 enables expansion of the spring duringposition of the two locking legs 4311 such that when release the tissueis folded away from the coiled shaped crossbar. Additional embodimentsof this device can include suture or polymer elements with distal tipcollapsible polymer umbrella shaped elements. Upon deployment thecollapsed polymer can be pushed through an introducer needle to theopposite side of the tissue layer to be plicated, introducer needleremoved and polymer umbrella shape allowed to naturally expand. Bothsides of this embodiment would be deployed simultaneously. Attachment ofthe suture or polymer connection elements to the polymer umbrella shapewould be at the central position of the umbrella. The umbrella elementwould be flexible, but stiff enough and large enough that it will notpull back through the tissue easily. The suture or polymer connectionwill have a degree of elasticity to allow for temporary stress relief.Visually this may appear as a contact lens with a center tether. Theadvantage of such an embodiment include the ability to plicate softtissues with materials and shapes that will be atraumatic to the tissuesif failure occurs, as well as have elastic properties that allow fortemporary stress relief. Further embodiments would include the use ofshape memory metals or shape memory polymer to deploy umbrella orvarious anchor shapes to plicate the tissue, achieving the same effectas described in the previous examples.

The exemplary embodiments shown in FIGS. 44 and 45 are single componentplication clip devices 4410 and 4510. Both of these embodiments arecircular rings with internal tooth elements 4411 and 4511 that are flator can be layered in rows (as in FIG. 45) or concave inward. The primarypurpose of the tooth elements 4411 and 4511 is to engage the tissue andprevent slipping of the tissue. Plication with these clips is performedas follows. A portion 4441 of tissue 4440 is grasped using thedeployment device, the tissue is wrung in either a clockwise orcounterclockwise direction for several rotations. As the tissue beginsto bunch up, the circular plication element 4410 is advanced over thetissue 4441 down to the base of the plication region. The tissue 4441 isthen released and allowed to expand. The expansion of this tissue locksthe clip into place, thereby holding the tissue in a plicated state. Theouter diameter of these rings can range from 2 to 20 mm and the innerdiameter from 1 to 18 mm.

The embodiment depicted in FIG. 46 is a single component clip device4610. This embodiment is a rectangular device that can be flat or curvedin either the in-plane and out-of-plane directions, making tissueconformity better. A purpose of the tooth elements 4611 is to engage thetissue and prevent slipping of the tissue. Plication with these clips isperformed as follows. A portion 4641 of tissue 4640 is engaged with thegrasping mechanism of the deployment device 4610. Tissue 4641 is thendrawn into the plication clip 4610 as the plication clip (deflected toexpand the clip opening) is advanced over the tissue pleat to the baseof the plication. The tissue and/or the plication clip are thenreleased. The expansion of this tissue locks the clip into place,thereby holding the tissue in a plicated state. Moreover, the directionof the teeth can be oriented to allow for the tissue to easily passthrough the device during plication. However, once deployed, the teeth4611 will engage the tissue 4641 when tension in applied to pull thetissue out. As a result, the clip will maintain a lock on the tissueensuring that the clip will be able to maintain the plication of thetissue. The outer dimensional ranges of the rectangular element are:length (2 to 40 mm) and width (1 to 10 mm). The inner dimensional rangesof the rectangular element are: length (1 to 38 mm) and width (0.5 to 9mm).

Variations of this embodiment are illustrated in FIGS. 47 to 51. FIG. 47illustrates an oval shaped plication clip 4710 with a center region thatcan be used to pass the clip into position, pass the grasper elementthrough the clip and draw the tissue pleat into the clip. This clip canbe deformed to have curvature in the in-plane and out-of-planedirections to allow for conformity with the tissue pleat. The teeth 4711in this embodiment and others described can have various shapes andpatterns that allow for tissue engagement or added friction to thetissue. Moreover, the teeth 4711 can also consist of various otherembodiments that allow for frictional as well as active engagement ofthe tissue pleat, for example bristles, flaps, or spikes. The size,width, pitch, depth of the teeth can be adjusted to optimize the holdingstrength and degree of engagement with the tissues.

FIG. 48 shows an embodiment with variable teeth sizes and shapes 4811and 4812. The general shape of the plication clip embodiment has curvededges to reduce the local stress on the tissue pleat caused by the clip.Moreover, the direction of the clip teeth are positioned to allow forengaging of the teeth into the tissue pleat if the pleat is tensioned(e.g., pulled) from the bottom, thus preventing release of the tissuepleat. The side rails of the embodiment are intended to allow for betterconformity between the clip and the tissue pleat.

FIG. 49 shows a variation of the embodiment shown in FIG. 48 where therails are positioned in the axis parallel to the tissue plane. Theembodiments shown in FIGS. 50 and 51 are additional variations inembodiments for methods to engage the tissue with the locking clips.Benefits of all of these clip designs includes irritation of thesynovium which will elicit a favorable biologic healing response. Thedesign of the clip teeth can be optimized to take full advantage of thischaracteristic. Furthermore, each of these above designs can bemanufactured from various material combinations or single materials(e.g., metals, polymers, shape memory alloys, etc.).

The embodiment shown in FIG. 52 is an example of using the plicationclip devices for the treatment of capsule to labrum plication. Shown aretop, side, and profile views of the plicated capsule to labrum tissues.The embodiments shown in the figure include the use of U-shapedplication clips 5240 in two orientations. Various other plication clipdesign described above can be used to achieve similar plication asshown. Primary factors that are considered for embodiments for thisplication include the potential for abrasion or interaction with thearticular surfaces as well as potential for loosening of the device. Theposition of the device relative to the glenoid articulating surface willbe sufficiently lateral as not to interact. Furthermore, the embodimentof the plication clip will be of small enough as not to protrude intothe glenoid articulating space. Additionally, the material used for theplication clip in this application will have ideal characteristicsrelative to stiffness and strength.

In operation, the plication clamp is used to grasp the capsule and pulla fold of capsular tissue into the clamp jaws. The clamp jaws are thenused to position the plication clip with one jaw passing through thecapsular fold and the other jaw passing through the labrum and then thecapsular fold. It should be noted that the capsule to labrum plicationcan be executed as a separate operation after placating the capsule(e.g., attached the already plicated capsule distal end to the labrum),a simultaneous step of placating the capsule directly to the labrum (asshown in FIG. 52), or a simultaneous reverse plication where a region ofthe capsule is pulled into direct contact with the labrum pushing thefold away from the jaws of the clamp.

Various appropriate materials may be used to construct the elements orvarious parts of the elements that comprise the exemplary embodimentsshown and described in this disclosure. For example, the locking baseand arms of clips, spikes, needle, grasper, or deployment devicecomponents that require the ability to have elastic properties relativeto being able to be deformed and deployed (returned to intended shape)using arthroscopic devices can be fabricated from various materials,including, but not limited to shape memory alloys (e.g., nickel titanium(Nitinol), shape memory polymers, polymers (e.g., PTFE, polyurethane,urethane, silicone, polyimide, polypropylene, Polylactic Acid,Polyglycolic Acid, or other thermoset or thermoplastic, or elastomericmaterials) and metals (e.g., titanium, CoCrMo, stainless steel, nickeltitanium, etc).

In some embodiments, the device clips or sutures may be resorbable, inother embodiments, the device components will have limited or noresorption characteristics. The clips components described in thisdisclosure can be made in part or solely of one material. Alternatively,the structures of the clips can be composed of metal and/or polymercomponents fabricated into composite devices. For example, low surfacearea and thin metal or metal alloy components that define the puncturingand/or locking components of the cups can be insert molded with apolymer (e.g., polypropylene) to produce a composite device that hasvery little radiopacity but exhibits excellent puncturing and lockingcharacteristics. Some embodiments may include parts that are resorbableand some that are not.

Fabrication of these clip components can be performed using techniquesfamiliar with manufacturing methods by those skilled in the art ofmetals, polymers, shape memory alloys, shape memory polymers, orcomposite materials. Sample techniques include, but are not limited to,extrusion, casting, press-forging, rolling, or pressing methods for thefabrication of parts for the above materials. In specific instances, theuse of techniques related to modification of polymer chemistry to adjustthe shape memory characteristics related to thermal conditions andelastic properties of the polymer will be utilized. With respect toshape memory metal materials, one skilled in the art will utilize thethermal characteristics of the specified composition to fabricatecomponents with the geometry and features required for the devicecomponent. Proper thermal forming and quenching is required to processthe material and is generally known to one skilled in the art of using,processing, and fabricating components out of shape memory materials.

In some embodiments several components may require parts using standardmachining techniques typically known to one skilled in the art ofmachining. For example, use of CNC, EDM, laser cutting, water jetcutting, polishing methods, and other machining techniques. Severalembodiments may also require bonding or welding of components andinclude adhesives, laser welding, soldering, or other means ofattachment.

Clip components that include spikes or needles may be fabricated fromany stock materials typically known to one skilled in the art of medicaldevice manufacturing. Attachment of suture or other clip materials tothese embodiments can be performed by tying, welding, bonding, clamping,embedding, or use of other such means for securing the spike or needleto the suture or other clip materials. In some embodiments, these spikesor needles can be mechanically polished or electropolished to producesmooth surfaces.

Various embodiments of the clip components described can be coated withor encapsulated with a covering of a polymer material that can allow forthe use of anti-proliferative, antibiotic, angiogenic, growth factors,anti-cancer, or other pharmacological substances that may provide abenefit related to inhibiting or promoting biological proliferation.These substances would be loaded into the encapsulating coatings and beallowed to elute into the surrounding matrix, tissues, or space that itsits. The time course of delivery can be tailored to the intendedapplication by varying the polymer or the characteristics of thecoating. Such coatings with pharmacological substances can act asanti-proliferative treatments or can aid in the healing response of thetissue being treated. Furthermore, these coatings can act to reduce thelocal coagulation or hyperplastic response near the chip.

Various examples of surgical procedures using the devices, systems andmethods of the present invention will be described in the non-limitingexamples provided below. In each example described, one or more of thevarious embodiments shown in FIGS. 2-52 may be used.

Example A Arthroscopic Repair of Bankart Lesion with Arthroscopic SuturePlication of Associated Anterior Capsular Laxity

Following examination under anesthesia and standard surgical preppingand draping, standard anterior and posterior glenohumeral arthroscopyportal are established. The patient may be positioned either in thelateral decubitus position or in a beach chair position. Followingcompletion of diagnostic arthroscopy, attention is first focused onrepair of the Bankart lesion. After the Bankart repair has beenperformed, residual anterior capsular laxity is assessed. The surgeonsubsequently places the humerus in the desired position (in terms ofexternal rotation and abduction; this will vary according to patientdemand and individual surgeon preference). With the shoulder placed inthe desired position, capsular redundancy is addressed via performing asuture plication. The capsular plication deployment device is introducedthrough a standard anterosuperior portal. Capsular grasper is deployedto create a capsular pleat delivering the capsular pleat into the jawsof the clip passing device. The clip device is subsequently deployed.Typically, two to four separate clip implant devices will be placed in asequential posteroinferior to anterosuperior direction along thecapsule. Additional clips may be placed to ensure that capsularredundancy has been adequately rectified. The amount of capsule deliveryinto the jaws of the clip passing device (and hence, the amount ofcapsular tightening) will vary according to surgeon preference and theamount of capsular laxity and patient demand. Of note, the Bankartrepair must be conducted first in order to adequately assess the amountof residual amount of capsular laxity and determine the ideal requiredamount of capsular tightening. One of the advantages of exemplarydevices according to the present invention is their ability to tightenthe capsule a variable amount based upon individual situations.Following completion of placement of the desired plications, thearthroscopic probe is introduced and each of the plications isindividually probed to confirm that the clip devices have been deployedin a stable fashion. The shoulder is place through a trial range ofmotion while the tensioned portion of the capsule is visualized to, onceagain, confirm that adequate fixation of each of the capsular plicationshas been achieved.

Example B Capsular Laxity without an Associated Bankart Lesion (e.g.,Anterior Unidirectional Atraumatic Instability)

Following examination under anesthesia, standard anterior and posteriorglenohumeral arthroscopic portals are established. A thorough diagnosticglenohumeral arthroscopy is performed with specific attention todetermining the extent and distribution of capsular laxity. With theshoulder positioned in the desired amount of abduction and externalrotation, the anterior capsule is tensioned via placement of anteriorcapsular plications in a posteroinferior to anterosuperior sequence viathe anterosuperior portal. The sequence of placement of successiveplication devices in a posteroinferior to anterosuperior direction isdetermined by virtue of the fact that if the anterosuperior capsule istensioned first then placement of the capsular plication deploymentdevice more inferiorly and posteriorly will be more difficult. However,tensioning the axillary pouch (posteroinferior section) first does notlimit access further anteriorly and superiorly on the inferiorglenohumeral ligament. Following completion of placement of the desiredplications, the arthroscopic probe is introduced and each of theplications is individually probed to confirm that the exemplary clipdevices have been deployed in a stable fashion. The shoulder is placedthrough a trial range of motion while the tensioned portion of thecapsule is visualized to, once again, confirm that adequate fixationthat each of the capsular plications has been achieved.

Example C Multidirectional Instability (MDI)

Following examination under anesthesia, standard anterosuperior andposterior glenohumeral arthroscopic portals are established and athrough diagnostic arthroscopy is performed. The redundant posteriorcapsule and posteroinferior capsule is tightened first. This isaccomplished via visualization through an accessory anterior portal. Thecapsular plication deployment device is introduced through the standardanterosuperior portal. The posterior capsule is visualized via placementof the arthroscope through the accessory anterior portal. Posteriorcapsular redundancy is reduced via placement of successive capsularplications posteriorly (in an inferior to superior sequence). Thearthroscope is subsequently reintroduced through the standard posteriorglenohumeral viewing portal and the standard anterosuperior portal isutilized to perform the capsular plications. The inferior and anteriorglenohumeral capsule is tensioned via placement of sequentially clipdevices according to exemplary embodiments of the present invention inan inferior to superior direction. Following completion of placement ofthe desired plications, the arthroscopic probe is introduced and each ofthe plications is individually probed to confirm that the clip deviceshave been deployed in a stable fashion. The shoulder is place through atrial range o motion while the tensioned portion of the capsule isvisualized to, once again, confirm that adequate fixation that each ofthe capsular plications has been achieved.

Example D Lung Volume Reduction Surgery (LVRS)

Preoperative imaging (e.g., radiographs, computed tomography) isperformed to identify the segments of the lung requiring volumereduction. Following anesthesia induction, the patient is position inthe lateral decubitus position to allow placement of thorascope as wellas another access port for the plication delivery device positioning.The lung is collapsed using standard techniques. Using the plicationdelivery device grasping mechanism, the region of lung tissue to bereduced can be retracted into the device. Care is taken in the placementof the access port for the plication device to insure that when thedevice is engaged with the lung tissue that the tissue is not deformedor stressed to a point where excessive trauma occurs. The identifiedlung tissue section to be reduced is grasped by the device jaws. Axialrotation of the device jaw will result in wringing of the lung tissue,FIG. 53. The wringing of the lung tissue will draw tissue surroundingthe point of grasping to be circumferentially pulled into the center.Once sufficient lung tissue is determined to be reduced, the plicationclip is advanced into position down the shaft of the delivery device.Advancement of the plication clip is continued until it is positioned atthe base of the wrung region, such as shown in FIG. 53. Typicaladvancement of the plication clip will range from 0.5 to 25.4centimeters from the tip to the base of the wrung lung tissue. Theplication is examined to insure proper alignment and deployment. Theresult of this plication will result in a reduced volume capacity of thelung, minimizing the effects of the diseased section of the lung. Oncethe plication clip is fully deployed, the grasper is released andplication device withdrawn. Additional regions of plication can also beaddressed at the same time. The use of these plication clips should notresult in the generation of air leaks of any significance. Furthermore,upon reinflation of the lung, evaluation of whether or not sufficientlung volume reduction is achieved can be evaluated. If necessary,standard chest tubes can be positioned anteriorly and posteriorly to theapex of the lung and suction initiated to remove excess fluid from thepleural cavity. Multiple plication clips are expected to be used toadequately reduce the lung volume.

Variations in the plication clip delivery may not require wringing ofthe tissue but rather only grasping of the tissue and then advancementof the clip over the tissue, as shown in the lung reduction procedureshown in FIG. 55. In these types of embodiments, the same range ofadvancement can be achieved (0.5 to 25.4 centimeters). Similarly,multiple devices can be deployed until adequate lung volume reductioncan be achieved.

Example E Laparoscopic Gastric Fundoplication with Laparoscopic Sutureor Clip Tissue Fixation

Following anesthesia induction, the patient is positioned, prepped anddraped in the standard fashion for an upper abdominal laparoscopicprocedure. Using standard laparoscopic technique, a trocar is introducedthrough the abdominal wall and a laparoscope is advanced into theabdomen to provide visualization. Additional trocars (3-4) are insertedto accommodate required instrumentation. Under direct laparoscopicvisualization, the surgeon elevates the liver to expose the junctionbetween the stomach and the esophagus. Using sharp and blunt dissection,the hiatal hernia is reduced by freeing the esophagus and the stomach ofsurrounding soft tissue connections around the diaphragmatic hiatus andpulling the stomach and about 5 or 6 cm of the esophagus down into theabdomen. A space is created behind the esophagus and the fundus of thestomach, exposing the diaphragmatic hiatus. The size of the hiatus(defined by the arches of the left and right crural fiber bands) isreduced by approximating the muscles of the left and right crura behindthe esophagus. The laparoscopic tissue fixation device is insertedthrough a trocar and advanced to the hiatus. Using a laparoscopic forcepthrough another trocar, the crural fibers are pulled so they areadjacent. The tissue grasper is deployed from the fixation device, andthe adjacent fiber bands grasped together and pulled between the jaws ofthe fixation device. The fixation device is activated, securing thecrural fibers with a suture, clip or other point fixation device. Theprocess is repeated, until the opening of the hiatus is adequatelyreduced, usually requiring two or three adjacent fixations, as shown inFIG. 54.

Using sharp dissection, the fundus of the stomach is freed of itsconnections, such as the short gastric vessels to the spleen and smallligaments connecting it to the left diaphragm. This mobilization createsa window behind the esophagus. The redundant portion of the stomachfundus on the left side is then pulled behind the esophagus to the rightside and then around the front of the esophagus, forming a wrap, asshown in FIG. 54. Depending on the type of procedure, the wrap may besecured partially or completely around the esophagus. For a partialwrap, laparoscopic forceps are used to position the ends of the wrapnext to the anterior wall of the esophagus, and prepared for thefixation device. The approximated tissues are grasped together using thetissue grasper, and the tissues pulled into the jaws of the device. Thefixation device is activated, securing the crural fibers with a suture,clip or other point fixation device. The process is repeated until theedge of the wrap is secured, usually requiring 2-4 fixations. Thefixation is repeated in a similar fashion for the other edge of thewrap. For a complete wrap, laparoscopic forceps are used to position theends of the wrap next to each other in front of the anterior wall of theesophagus. The wrap is prepared for fixation by grasping both left andright edges of the wrap with a pleat of anterior esophageal wallsandwiched in between. The approximated tissues are grasped togetherusing the tissue grasper, and the tissues pulled into the jaws of thedevice. The fixation device is activated, securing the wrap andesophageal tissues with a suture, clip or other point fixation device.The process is repeated until the edge of the wrap is secured, usuallyrequiring 2-4 fixations.

Example F Laparoscopic Hernia Repair with Laparoscopic Suture or ClipTissue Fixation

Following anesthesia induction, the patient is positioned, prepped anddraped in the standard fashion for an abdominal laparoscopic procedure.Using standard laparoscopic technique, a trocar is introduced throughthe abdominal wall and a laparoscope is advanced into the abdomen toprovide visualization. Additional trocars (2-3) are inserted toaccommodate required instrumentation. Under direct laparoscopicvisualization, the hernia contents are reduced by taking down theadhesions to the abdominal wall and within the hernia sack itself. Oncethe abdominal wall is free, a tightly rolled prosthetic patch or mesh isinserted through one of the ports into the abdomen, where it is unrolledand positioned under the defect. The patch may be placed on theperitoneum or the peritoneum may be opened and the patch placed betweenthe peritoneum and abdominal fascia. Several sutures may be used toanchor the patch in place to the abdominal fascia. The laparoscopictissue fixation device is inserted through a trocar and advanced to thepatch. Using a laparoscopic forcep through another trocar, the edge ofthe patch and peritoneum or fascia are pulled so they are adjacent. Thetissue grasper is deployed from the fixation device, and the edge of thepatch and peritoneum or fascia are grasped together and pulled betweenthe jaws of the fixation device. The fixation device is activated,securing the patch to the peritoneum or fascia with a suture, clip orother point fixation device. The process is repeated, until the edges ofthe entire patch are secured to the peritoneum or fascia at 1 cmintervals to prevent internal hernia. The patch size is usually 8 to 10cm larger than the defect, in effect reconstructing the abdominal wall.If the peritoneum was opened, this is now closed over the patch.

Example G Thoracoscopic Mitral Valve Repair with Thoracoscopic Suture orClip Tissue Fixation

Following anesthesia induction, the patient is positioned, prepped anddraped in the standard fashion for a right chest thoracoscopicprocedure. Using standard thoracoscopic technique, a trocar isintroduced through the thoracic wall and a thoracoscope is advanced intothe right pleural space to provide visualization. Additional trocars(2-4) are inserted to accommodate required instrumentation. CO₂insufflation may be used to displace the left lung and enhancevisualization. A small intercostal incision may be used as a workingportal in addition to the trocar ports.

Mitral valve reconstruction may be performed alone or as a part ofanother thoracoscopic cardiac procedure. Under direct thoracoscopicvisualization, the pericardium is opened anterior to and parallel to theright phrenic nerve using scissors. The patient is systemicallyanticoagulated and cardiopulmonary bypass is instituted by cannulationby femoral approach or by direct cannulation through the thoracicincisions. The heart is arrested and vented.

Using sharp dissection, the left atrium is entered by incision eitheranterior to the right pulmonary veins or through exposure through theatrial septum. The mitral valve is exposed with retractors andinspected. Leaflet resection and repair may be performed as indicated bythe underlying pathology. For example, isolated posterior leaflet cuspprolapse may be treated by a triangular or quadrangular resection. Afterresection of the flail cusp using scissors, the annulus diameter isreduced adjacent to the defect by plicating the annulus. Using athoracoscopic forcep, the annular tissue is grasped and elevated. Thetissue grasper is deployed from the fixation device, and the elevatedannular tissue is grasped and pulled between the jaws of the fixationdevice. The fixation device is activated, plicating the annulus togetherwith a suture, clip or other point fixation device. One or more adjacentplication points may be required to create sufficient annular reduction.Using a forcep, the cut edges of the valve leaflet are approximated. Thetissue grasper is deployed from the fixation device, and the adjacentedges of the valve is grasped and pulled between the jaws of thefixation device. The fixation device is activated, securing the edges ofthe leaflet together with a suture, clip or other point fixation device.Two or more adjacent fixation points may be required to create acontinuous line of fixation, FIG. 56.

The valve repair is then reinforced with a partial or completecircumferential annuloplasty ring. A forcep is used to bring the ring tothe annulus adjacent to one of the commissures, and the combination isgripped by the tissue grasper in the fixation device and pulled betweenthe jaws of the fixation device. The fixation device is activated,securing the ring to the annulus with a suture, clip or other pointfixation device. This is repeated at the other commissure. Using forcepsto adjust the relative spacing, additional adjacent fixation points areserially fashioned to create a continuous line of attachment between thering and the annulus. The valve is then tested to assure competency. Theatriotomy edges are approximated, then grasped and secured using thefixation device. This is repeated at adjacent points along the edgesuntil the incision satisfactorily closed. The heart is de-aired,reperfused, normal rhythm restored, and cardiopulmonary bypassterminated.

Example H Thoracoscopic Left Atrial Appendage Ligation withThoracoscopic Suture or Clip Tissue Fixation

Following anesthesia induction, the patient is positioned, prepped anddraped in the standard fashion for a left chest thoracoscopic procedure.Using standard thoracoscopic technique, a trocar is introduced throughthe thoracic wall and a thoracoscope is advanced into the left pleuralspace to provide visualization. Additional trocars (2-4) are inserted toaccommodate required instrumentation. CO₂ insufflation may be used todisplace the left lung and enhance visualization. Left atrial appendageligation may be performed alone or as a part of another thoracoscopicprocedure. Under direct thoracoscopic visualization, the pericardium isopened anterior to and parallel to the left phrenic nerve usingscissors, FIGS. 57A and 57B. The appendage of the left atrium isidentified, and mobilized using sharp and/or blunt dissection. Using athoracoscopic forcep introduced through a trocar, the tip of theappendage is gently manipulated so that the base of the appendage can bevisually inspected to determine the location for the ligation line. Thetissue grasper is deployed from the fixation device, and the edge of theatrial appendage is grasped and pulled between the jaws of the fixationdevice. The fixation device is activated, securing walls of theappendage together with a suture, clip or other point fixation device.One or more adjacent fixation points may be required to create acontinuous line of ligation. The fixation device jaws are opened, thetissue released, the device repositioned and the process repeated untilthe walls of the appendage are completely secured from edge-to-edgealong the planned line of ligation. The appendage ligation line isinspected for hemostasis, and a soft drain may be brought through anopening in the chest wall and directed into the pericardial space.

Using a thoracoscopic forcep, the edges of the opening in thepericardium are brought into approximation. The tissue grasper isdeployed from the fixation device, and the pericardial edges are graspedand pulled between the jaws of the fixation device. The fixation deviceis activated, securing the pericardial edges together with a suture,clip or other point fixation device. One or more adjacent fixationpoints may be required to adequately re-approximate the pericardium. Adrain may be brought through an opening in the chest wall and directedinto a dependent area of the thoracic space for postoperative pleuraldrainage.

The foregoing disclosure of the preferred embodiments of the presentinvention has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Many variations andmodifications of the embodiments described herein will be apparent toone of ordinary skill in the art in light of the above disclosure. Inparticular, the many examples shown above that relate to the shouldercapsule and plication are not limited to such, and may be applied to anytissue or tissue structure as well as any type of repair performedthereon. The scope of the invention is to be defined only by the claimsappended hereto, and by their equivalents.

Further, in describing representative embodiments of the presentinvention, the specification may have presented the method and/orprocess of the present invention as a particular sequence of steps.However, to the extent that the method or process does not rely on theparticular order of steps set forth herein, the method or process shouldnot be limited to the particular sequence of steps described. As one ofordinary skill in the art would appreciate, other sequences of steps maybe possible. Therefore, the particular order of the steps set forth inthe specification should not be construed as limitations on the claims.In addition, the claims directed to the method and/or process of thepresent invention should not be limited to the performance of theirsteps in the order written, and one skilled in the art can readilyappreciate that the sequences may be varied and still remain within thespirit and scope of the present invention.

1-21. (canceled)
 22. A system for transdermal repair of soft tissue, thesystem comprising: a first element for securing and moving a portion ofsoft tissue that is to be repaired, the first element having anundeployed retracted state and a deployed extended state; a secondelement for repairing the portion of soft tissue that is secured by thefirst element, the second element having jaws that clamp down on theportion of soft tissue in order to retain the portion of soft tissue forthe transdermal repair; and a third element for actuating the firstelement and the second element in turn for performing the transdermalrepair; wherein the first element is disposed within the jaws of thesecond element when it is in its undeployed retracted state, and isdisposed outside of the jaws of the second element when it is in itsdeployed extended state.
 23. The system as recited in claim 22, whereinthe first element, in its deployed state, captures the portion of softtissue and then is retracted to its undeployed state to bring theportion of soft tissue to a location within the jaws of the secondelement.
 24. The system as recited in claim 22, wherein the portion ofsoft tissue comprises an interior concave surface of a capsular body,and the transdermal repair comprises plication.
 25. The system asrecited in claim 22, and further comprising a neuro-stimulator forstimulating nerves near the portion of soft tissue, so that a user issignaled of the presence of a nearby nerve.
 26. The system as recited inclaim 25, wherein said neuro-stimulator comprises a probe element whichcomprises a portion of said first element.
 27. The system as recited inclaim 22, wherein at least one of the first and second elements includesabrading tools for abrading the portion of soft tissue in order toirritate the tissue and aid in natural tissue repair.
 28. The system asrecited in claim 22, wherein the second element utilizes a suture torepair the portion of soft tissue.
 29. The system as recited in claim28, wherein the suture remains attached to the second element after thesoft tissue is repaired and the jaws of the second element are opened.30. The system as recited in claim 28, wherein the suture isautomatically released from the second element after the tissue isrepaired and the jaws of the second element are opened.
 31. The systemas recited in claim 22, wherein the second element employs a tissuelocking mechanism to repair the portion of soft tissue.
 32. The systemas recited in claim 31, wherein the tissue locking mechanism comprises:an anchor element having a shaft with two penetrating ends forpenetrating the soft tissue, wherein each penetrating end has a movableanchor stop which permits the end to penetrate tissue initially, andthen turns to lock the anchor stop on the side of the portion of softtissue that is opposite to the side of the shaft.
 33. The system asrecited in claim 31, wherein the tissue locking mechanism furthercomprises: a first anchor element having a shaft with a penetrating endto penetrate soft tissue, and a receiving end to accommodate thepenetrating end, wherein the first anchor element at least partiallycontains a metallic interior to assist in the maintenance of its shape,and wherein the penetrating end and the receiving end communicate toplicate the soft tissue held within.
 34. The system as recited in claim31, wherein the tissue locking mechanism further comprises: apenetrating element having a point and a perpendicular stop; and anaccommodating element having a point receiving slot and a perpendicularstop, wherein the penetrating point and the accommodating point plicatetissue between each of the perpendicular stops by mating the point onthe penetrating element with the point receiving slot on theaccommodating element.
 35. The system as recited in claim 31, whereinthe tissue locking mechanism further comprises: a substantially planarsurface having an opening therein and a plurality of teeth positionedinwardly toward the opening, wherein a portion of the captured softtissue is pulled within the opening and plicated therein by theplurality of teeth when the tissue is released.
 36. A system forplicating a capsular structure, the system comprising: a pinchingelement for pinching and capturing a portion of an interior surface of acapsular structure to be plicated, the pinching element having adeployed extended state and an undeployed retracted state; a plicatingelement for plicating the portion of the interior surface of thecapsular structure that has been captured by the pinching element; and adeployment element for actuating the pinching element and the plicatingelement in turn to plicate the portion of the interior surface of thecapsular structure which is captured; wherein the pinching element isdisposed within an interior portion of the plicating element when it isin its undeployed retracted state, and is disposed outside of and asubstantial distance from the interior portion of the plicating elementwhen it is in its deployed extended state.
 37. The system as recited inclaim 36, and further comprising a plicating actuator to lock theplicating element on the portion of the captured portion of the interiorsurface of the capsular structure.
 38. The system as recited in claim36, wherein the interior surface of the capsular structure has a concavegeometry.
 39. The system as recited in claim 36, wherein the plicatingelement includes a suture.
 40. The system as recited in claim 36,wherein the plicating element includes a locking mechanism comprising asingle body.
 41. The system as recited in claim 36, and furthercomprising a neuro-stimulator for stimulating nerves near the portion ofthe interior surface of the capsular structure to be captured, so that auser is signaled of the presence of a nearby nerve.
 42. The system asrecited in claim 36, and further comprising abrading elements forabrading the portion of the interior surface of the capsular structureand thus irritate the interior surface to aid in natural tissue repair.